Role of preoperative chlorhexidine mouth wash in the prevention ofpostoperative respiratory complications
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: J159||Unspecified bacterial pneumonia,
- Registration Number
- CTRI/2024/06/069511
- Lead Sponsor
- Council for science and technology UP
- Brief Summary
CONCEPT-PROPOSAL
1. Title of the proposed researchproject: Roleof preoperative chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patientswith poor oral hygiene undergoing elective surgery - randomized controlled trial
2. Rationale:Postoperative respiratory complications account for asubstantial proportion of morbidity and mortality relatedto surgery and anesthesia. Severalstudies aimed at identifyingrisk factors and and predictors have been conducted across the world. Various studies have shownpatients with poor oral hygiene such as active caries and high plaque deposition are at higher risk of developing postoperative pulmonary complications.Gram negative, anaerobic, periodontal pathogens form biofilms on dental plaquesand multiply within them subsequently resulting in periodontal disease, when left untreated. This is especially significant in the Indianscenario where a vast majority of patients belong to the lower socioeconomic status and lack of oral care is more prevalent in this strata. In addition,studies have also focused on the prevention andtreatment of postoperative pulmonary complications and have found that active preoperative oral care withchlorhexidine mouth wash plays an importantrole in preventing and reducing the development of postoperativepulmonary complications bydisinfecting the oral cavity. It has also shown to reduce incidence ofsurgical site infections and the length of hospital stay However, most of these studies have been limited topatients undergoing major thoracic, cardiac and bowel relatedsurgeries and elderlypatients with multipleco- morbidities. The role ofpreoperative oral hygiene in preventing or reducing postoperative pulmonary complications in patients undergoingother surgeries, particular shortduration surgeries, is yet to be studied. Also, the existing studieshave focused on pneumonia as the major complication. While pneumoniaand respiratory failure are the major contributors to morbidity and mortality, others such as unexplained fever, excessive bronchialsecretions, productive cough,abnormal breath sounds, atelectasis or hypoxaemia are often overlooked but can significantly prolongduration of hospital stay and increase medicalcost which can be avoided. This study thus aims to identify the role of preoperative oral care in the form of chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poororal hygiene undergoing elective surgeryunder general anesthesia.
3. Novelty/Innovation: Existing studies have particularly targeted thoracic,cardiac, bowel surgeries, neurosurgeriesand elderly patients with multiple comorbidities with focus on the incidence of postoperative pneumoniain particular. These surgeries frequently require postoperative mechanicalventilation with higher probability ofdeveloping postoperative pneumonia, irrespective of oral hygiene status and make up only a small fraction of thespectrum of surgeries performed. In our study,we seek to see the role of oral hygiene independently, by removing the bias of surgerieswith a higher risk of pulmonary complications, based on incidence of pneumonia as well as othercomplications such as, unexplained fever, excessivebronchial secretions, productive cough, all of which significantly contribute to perioperative morbidity.
4. Project Description:The proposedstudy is a prospective randomized double blind controlled trial. It will be conductedby department of anesthesiology, King George’s MedicalUniversity, Lucknow after getting ethicalapproval, in collaboration with the department of microbiology, generalsurgery and department of dental sciences, KingGeorge’s Medical University, Lucknow. The research will be conducted over a total period of three years of which30 months will be dedicated to thestudy and six months each will be reserved for data collection and biostatistics.
Sample size :The sample size was calculated based on a previous study thatreported that the prevalence ofdental problems was 75% in India (Varghese et al,,2019), 95% level of confidenceand Error rate, usually set at 0.05 level is 4. Total 288 patients will be includedin this study.
**n=Z****2** **P(1-P)/d****2**
Where,
â— n = samplesize,
â— Z = Z statistic for a level of confidence, for the level of confidenceof 95%, which isconventional, Z value is 1.96.
â— P = expectedprevalence or proportion (in proportion of one; if 75%, P = 0.75),
â— d =precision (in proportion of one; if 5%, d = 0.05).
**n=**1.96x1.96x0.75x0.25/0.052
n=288.12
VargheseCM, Jesija J S, Prasad JH, Pricilla RA. Prevalence of oral diseases and risks to oral health in an urban communityaged above 14 years. Indian J Dent Res 2019;30:844-50
Expected outcome: Based onthe trend seen in preceding studies, we expect to find a positive co-relation between the use of preoperativechlorhexidine mouthwash in preventingpostoperative pulmonary complications particularly in patients undergoing generalanesthesia.
**Feasibility:**
**5.** **Strength of PI**
Dr Shefali Gautam, presently working asadditional professor ,KGMU in department of Anaesthesiology and Critical Care. Ihave total ten years experience of research activities. She has published 36publications in various peer reviewed journals. Since the year 2015 ,she isworking as faculty at KGMU. She has supervised 6 thesis as guide ,co-supervised14 MD/MS thesis and supervised 40 PG dissertations. In this project she will beresponsible for all experimental work and she will coordinate between thedepartment of general surgery and microbiology who are also part of this project.To keep herself updated with new research findings ,she regularly attends and conducts conferences, seminar andworkshops.
**6.** **Institutional Support:**
Our institute has well developed microbiology department for all routine blood investigations and culture and pre and post op facilities.
FORMAT OF RESEARCHPLAN1. Title of the proposedresearch project:Role of preoperative chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patientswith poor oral hygiene undergoing elective surgery under generalanaesthesia - randomized controlled trial
2. Summary:Background: Postoperative pulmonarycomplications (POPC) considerably contribute to perioperative morbidity andmortality. We have hypothesized that preoperative oral care in patients with poor oral hygiene can prevent the development of postoperative respiratory complications like pneumonia.
Novelty: All related studies have been limited to majorsurgeries that have a higherpredisposition for postoperative pneumonia. Tilldate, no other study has focused onmultiple types of surgeries and postoperative respiratory complications other than pneumonia.
Objective: The primary objective is to see the incidence of postoperative complications, namely sore throat, fever, pneumonia, upperrespiratory tract infections, lowerrespiratory tract infections, abnormal breath sounds in both the groups. The secondary objectives are tosee its role on surgical site infections and duration of hospital stay.
Methods: Patientsbetween 18-65 years of age with Oral Hygiene Index(OHI) more than 6, undergoingelective open abdominal surgery of less than 4 hours duration divided into 2 groups randomly. Patients with active URTI/LRTI,COPD/asthma, active smokers,with alcohol abuse, diabetes mellitus,morbid obesity, any immune deficiency, heart insufficiency, those with known allergy to chlorhexidine,those on broad spectrum antibiotics and negative consent to participate intrial will also be excluded from thestudy. All the patients will be given preoperativeantibiotic prophylaxis with inj. cefuroxime 750 mg iv along with the twopostoperative doses. Group A will receive 10 ml of chlorhexidine mouthwash 0.2%(w/v) while group B will receive 10ml of saline mouthwash for oral rinse for 10minutes. Tracheal aspirate [broncho alveolar lavage] for culture will becollected just prior to extubation in all patients and on post operative day 3,and 7 if any patient develops signs of infection. CBC, Chest X Ray and CRP willbe sent on day 3 and 7 days respectively and accordingly. Core body temperature,incidence of sore throat, excessive bronchial secretions, productive cough,abnormal broth sounds and need for supplemental oxygen will be monitored till postoperative day 7.
3. Keywords:Oral hygiene, chlorhexidine, respiratory complications,general anaesthesia
4. Abbreviations:POPC-postoperative pulmonary complications OHI- Oral hygiene Index
URTI- upperrespiratory tract infection LRTI- lower respiratory tract infection
COPD-Chronic Obstructive Pulmonary disease GA- general anaesthesia
DI-DebrisIndex CI- Calculus Index
VAP- ventilator associated pneumonia
5. Background:Postoperative respiratory complications account for asubstantial proportion of morbidity and mortality relatedto surgery and anaesthesia. Severalstudies aimed at identifyingrisk factors and and predictors have been conducted across the world. Various studies have shownpatients with poor oral hygiene such as active caries and high plaque deposition are at higher risk of developing postoperative pulmonary complications.Gram negative, anaerobic, periodontal pathogens form biofilms on dental plaquesand multiply within them subsequently resulting in periodontal disease, when left untreated. Translocation of these pathogenic bacteria leads to respiratory infections.This is especially significant in theIndian scenario where a vast majority of patients belong to the lower socioeconomic status and lack oforal care is more prevalent in this strata.In addition, studieshave also focusedon the prevention and treatmentof postoperative pulmonarycomplications and have found that active preoperative oral care with chlorhexidine mouth wash plays an important rolein preventing and reducing thedevelopment of postoperative pulmonary complications by disinfecting the oral cavity. It has also shown to reduce incidence of surgical site infections and the length of hospitalstay However, most of these studies havebeen limited to patients undergoing major thoracic, cardiac and bowel related surgeries and elderly patientswith multiple co-morbidities. The role of preoperativeoral hygiene in preventing or reducing postoperative pulmonary complications in patients undergoing othersurgeries, particular short duration surgeries, is yet to be studied. Also, the existingstudies have focused on pneumonia as the major complication. While pneumonia and respiratory failure
are the major contributors to morbidity and mortality, others such as unexplainedfever, excessive bronchial secretions, productive cough, abnormal breath sounds, atelectasis or hypoxaemia are often overlooked but can significantly prolong duration of hospitalstay and add to the burden of medical cost which can be avoided. This study thus aims to identify the role of preoperative oral care in the form of chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poororal hygiene undergoing elective surgeryunder general anaesthesia(GA).
6. Literature Review:**Ploenes T etal(2022)****[1]**carried outa prospective observational study on 230 adult adult patients undergoing elective thoracic surgery to see the co-relation of oral health status on perioperative outcomes. They found thatpatients with frequent dental visits and treated teeth had a lower risk for postoperative complications compared with patients without regular visits andpatients with a high burden of carieshad a significantly increased risk for pneumonia. They thus concluded that pathological oral health status is a modifiable factor predicting postoperative complications andpneumonia.
**Itohara C etal(2020)****[2]**conducted a retrospective observationalstudy on 441 consecutive patients whounderwent surgery for lung cancer to evaluate the trends in the number of oral bacteriain the perioperative period and to verifythe relationship between oral health status and postoperative feverusing an oral bacteria counter. All patients receivedperioperative oral management (POM) by oral specialists. Statistical analysisrevealed significantly higher oral bacteria countsat pre-hospitalization compared to pre- and post-operation (p < 0.001). They also found that POM can reduce the level of oral bacterialcounts, that the risk of postoperativecomplications is lower with dentulous patients, and that appropriate POM is essential for prevent of complications.Therefore, they stated that POM may play an important rolein perioperative management of lung cancer patients.
**Ogawa PT et el(2020)****[3]** conducted a retrospective cohort study on 884 consecutive patients who underwentelective cardiovascular surgery to assess theimpact of oral heath status on postoperative complications. They assessed the oralhealth status based on the number of remaining teeth, use of dentures, occlusalsupport, and periodontal status and investigated postoperative complications.On analyzing the collected data they found that prevalence of postoperative pneumonia and reintubationafter surgery was significantly higher in patients with severe tooth loss (P < 0.05 for both).
**Bardia A etal(2019)****[4]**conducted a systemic review andmeta-analysis of 5 studies that assessed the effects of preoperative chlorhexidine gluconate mouthwash onpostoperative pneumonia. Out of the2284 patients that were included, atotal of 1125 patients received preoperative chlorhexidine. All the studiesrevealed that use of chlorhexidine gluconate was associated with reduced risk ofpostoperative pneumonia compared with the patients who did not receive it (risk ratio, 0.52; 95%confidence interval, 0.39-0.70; P<.001). Noadverse effects from chlorhexidine gluconate mouthwash were reported byany of these studies.
**Soutane DDS et al(2017)****[5]** included 539 patients with esophageal cancer undergoing surgeryin a multicenter case controlstudy to investigate the effectiveness oforal care in prevention of postoperative pneumonia. Patients receivedoral health instruction, removal of dental calculus (scaling), professional mechanical tooth cleaning (PMTC),removal of tongue coating with a toothbrush, cleaning denture, and extraction of teeth with severe periodontitis showing pain, pus discharge,mobility, or marked alveolar bone loss by X-ray examination. Patients were instructed to clean teeth by toothbrush, interdental brush, dentalfloss, followedby gargling 3 timesaver day. At the end of their study, they found that longer operation time, postoperativedysphagia, and lack of oral care intervention to be)significantly correlated with postoperative pneumonia.
**Abbas K, AhmadSK(2016)****[6]** carriedout a randomised control trial to evaluate theuse of the preoperative chlorhexidine antiseptic mouthwash on the incidence of postoperative pneumoniaon 385 patients undergoing thoracicsurgery. Patients were randomly dividedinto two groups,one group(A) was given chlorhexidine mouthwash 10ml of 0.2% (w/v)preoperatively and the other (B) wasn’t.They observed that the incidence of the postoperative pneumonia was significantly reduced in the patientstreated with preoperative chlorhexidine mouthwash(group A 10.52% v group B 2.56% p=0.003). The length of hospital stay was also found to be significantly shorterin the chlorhexidine group. VAP developmentrate was significantly higher in the control group than in the CHX group (68.8% vs. 41.4%, respectively; p = 0.03) with an odds ratio of 3.12 (95%confidence interval = 1.09-8.91). Thus they came to the conclusion that oral care with CHX swabbingreduces the risk of VAP development in mechanically ventilated patients.
**Lin Y etal(2015)[7]** performed a prospective randomizedcontrolled trial to investigate the effect of preoperative 0.2% chlorhexidine on postoperative
ventilator associated pneumonia(VAP). Ninety-four patientsscheduled for heart surgery were randomized to achlorhexidine group (N = 47) or control (saline)group (N = 47). On the day before surgery, patients gargled three times with 0.2% chlorhexidine or saline 30 minafter each meal and 5 min after teeth brushingat bedtime. VAP occurred in 8.5% of the chlorhexidine group and in 23.4% of the controls. Preoperative chlorhexidine mouthwash reducedthe incidence of postoperative VAP significantly.
**Nicolosi L etal(2014)****[8]** carriedout a quasi-experimental study on 300 patientsundergoing heart surgery to determine the effect of toothbrushing plus0.12% chlorhexidine gluconate oral rinse in preventing VAP after CVS.
Patients in group 1 were enrolled in aprotocol for controlling dental biofilm by properoral hygiene (toothbrushing) and oral rinses with 0.12% chlorhexidine gluconate and they were compared with ahistorical control group (Group 2), whichincluded patients who underwent cardiac surgery between 2009 and 2010 and who receivedregular oral hygiene care. Seventy-two hours before surgery,a dentist provided instruction and supervised oral hygiene withtoothbrushing and chlorhexidine oralrinses to patients in Group 1. Statistics analysis showed alower incidence of VAP and a shorter hospital stay in Group 1The risk for developingpneumonia after surgery was 3-fold higher in Group 2 hence they came up with the cponclusion that oral hygieneand mouth rinses with chlorhexidine under supervision of adentist proved effective in reducing the incidence of VAP.
**Ozcaka O et al(2012)****[9]** conducted a randomised, double-blind, controlled
study on sixty-onedentate patients scheduledfor invasive mechanical ventilation for at least 48 hours. As these patients werevariably incapacitated, oral care was providedby swabbing the oral mucosa four times/datwith chlorhexidine in the CHX group(29 patients) and with saline in the controlgroup (32 patients). Clinical periodontal measurements were recorded, and lower-respiratory-tractspecimens were obtained for microbiological analysis on admission and when VAP was suspected. Pathogenswere identified by quantifying colonies using standard culturetechniques.
**Bagyi et al(2009)****[10]** conducted a study on a matched cohort of 18 patients without postoperative lung complicationscomparing them to 5 patients who developedpneumonia within 48 hours after elective brain surgery. Patients underwent preoperative dental examinationand saliva collection before surgery andwere given 15 mg/kg cefazolin intravenously at the beginning of surgery. Serum, saliva and bronchial secretionwere collected promptlyafter the operation. They observed that the numberand severity of coexisting periodontal diseaseswere significantly greater in patients with postoperative pneumonia in comparison to the controlgroup and the relative risk of developing
postoperative pneumonia in high periodontal scorepatients was 3.5 greater than inpatients who had low periodontal score (p < 0.0001). Thus they concluded that presence of multiple periodontaldiseases and pathogenic bacteria in the salivaare important predisposing factors of postoperative aspiration pneumonia in patients after brain surgeryand dental examination may be warranted in order to identifypatients at high risk of developing postoperative respiratory infections.
**Houston S etal(2002)****[11]** performeda prospective, randomized, case-controlled clinical trial to test the effectiveness of 0.12% chlorhexidine gluconate oral rinse in decreasing microbial colonization of the respiratory tract and nosocomial pneumonia in patientsundergoing open heart surgery. A total of 561 patients undergoing aortocoronary bypass or valve surgery requiringcardiopulmonary bypass were randomized to an experimental (n = 270)group that received 0.12%chlorhexidine gluconate or a control (n = 291) group that receivedListerine (phenolic mixture). Nosocomial pneumonia was diagnosed by using the criteria established by the Centersfor Disease Controland Prevention. overall rateof nosocomial pneumonia was reduced by 52% (4/270 vs 9/291; P = .21) in the Peridex-treated patients. Amongpatients intubated for more than 24 hours who had cultures that showed microbialgrowth (all pneumonias occurred in this group), thepneumonia rate was reduced by 58% (4/19 vs 9/18; P = .06) in patientstreated with Peridex.In patients at highest risk for pneumonia(intubated > 24 hours, with cultures showingthe most growth), the rate was 71% lower in the Peridex group than in the Listerine group (2/10 vs7/10; P = .02).
**DeRiso A et al(1996)****[12]** did a prospective,randomized, double-blind, placebo- controlledclinical trial to test the effectiveness of oropharyngeal decontamination on nosocomial infections in a comparativelyhomogeneous population of patients undergoing heart surgery. Three hundred fifty-three consecutive patients undergoing coronary artery bypass grafting,valve, or other open heart surgicalprocedures were randomized to an experimental (n=173) or control (n=180) group. The experimental drug chosen was 0.12% chlorhexidine gluconate (CHX) oral rinse. They foundthat the overall nosocomial infection ratewas decreased in the CHX-treated patients by 65%, the incidence of total respiratory tract infections in theCHX-treated group was reduced by 69%. Gram-negativeorganisms were involved in significantly less (p<0.05) of the nosocomial infections and totalrespiratory tract infections by 59% and 67%,respectively. They also noted a reduction in mortality in theCHX-treated group. Thus theyconcluded that oropharyngeal decontamination with Chlorhexidine oral rinse reduces the total nosocomialrespiratory infection rate and the use of nonprophylactic systemicantibiotics in patientsundergoing heart surgery.
7. Novelty:Existing studies have particularly targeted thoracic,cardiac, bowel surgeries, neurosurgeriesand elderly patients with multiple comorbidities with focus on the incidence of postoperative pneumoniain particular. These surgeries frequently require postoperativemechanical ventilation with higher probabilityof developing postoperative pneumonia, irrespective of oral hygienestatus and make up only a smallfraction of the spectrum of surgeries performed. In our study, we seek to see the role of oral hygiene independently, byremoving the bias of surgeries with a higher risk of pulmonary complications, based on incidence of pneumonia as well as othercomplications such as, unexplained fever, excessivebronchial secretions, productive cough, all of which significantly contribute to perioperative morbidity.
8. Study Objectives:The primary objective of the study is to see theincidence of postoperative complications,namely sore throat, pneumonia, fever,URTI, LRTI, abnormal breath sounds in both groups.
The secondary objectives are to see its role on surgicalsite infections and duration of hospital stay.
9. Methodology:**i.****Study Design:** A randomized controlled trial
**ii.** **Sample Size:**
The samplesize was calculated based on a previous study that reportedthat the prevalence of dental problems was 75% in India (Varghese et al,, 2019), 95% level of confidence and Error rate, usually set at 0.05 level is
4. Total 288 patients will be includedin this study.
**n=Z****2** **P(1-P)/d****2**
Where,
â— n = samplesize,
â— Z = Z statistic for a level of confidence, for the level of confidenceof 95%, which is conventional, Z value is 1.96.
â— P = expectedprevalence or proportion (in proportion of one; if 75%,P = 0.75),
â— d = precision (in proportion of one; if5%, d = 0.05).
**n=**1.96x1.96x0.75x0.25/0.052
n=288.12
Varghese CM, Jesija J S, Prasad JH, Pricilla RA. Prevalence of oral diseases and risks to oral health in anurban community aged above 14 years. Indian J Dent Res 2019;30:844-50
iii. Project implementation plan:The proposed study is a prospective randomized controlled double blindedstudy aimed to identify role of chlorhexidine mouthwash in preventing postoperative respiratory complications in patients undergoing elective surgeries under general anaesthesia.
Patients of ASA grade I/II, with poor oral hygiene (OHImore than 6), between 18-65 years ofage posted for elective abdominal surgeries of less than 4 hours duration under general anaesthesia usingendotracheal tube were included in the study.Patients undergoing laparoscopic surgeries, thoracic, cardiac and major bowel surgeries and patients in which supraglottic devices were used for GA were excluded from the study. Patientswith active URTI/LRTI, COPD/asthma, active smokers,with alcohol abuse, diabetes mellitus,morbid obesity, any immune deficiency, heart insufficiency, those with known allergy to chlorhexidine,those on broad spectrum antibiotics and negative consent to participate intrial will also be excluded from thestudy. Patients who have not smoked for a year or longer will be classified as not having a smoking habit. Patients in whom promptpostoperative extubation could notbe anticipated or neurological complications appeared, or those requiring re-intubation orre-exploration and those surgeries that extendbeyond 4 hours will bedropped from the study.
A routine standardpreoperative check up will be done. Oral examination willbe done by an experienced dentist. Eligibility and oral hygiene statuswill be graded by the Oral HygieneIndex (OHI). OHI is a dental index to assess the level oral hygiene a patient and has two components, DebrisIndex(DI) and Calculus Index(CI). These indices intern is based numerical determinant representing the amount of debris and calculus found on thebuccal and lingual surfaces of eachof the three segments of both the dental arches. The maxillary and mandibular arches are divided into 3segments each. Segments 1 and 3 are distal to the left and rightpremolars respectively whilesegment 2 extends
between the canines.Each segment is represented by one tooth that has the most surface area covered by debris orcalculus. Only fully erupted permanent teethare scored and third molar and partially erupted teeth are not included. Debris is defined as soft foreign materialloosely attached to a tooth surface. Calculusis a hard deposit formed by the mineralization of dental plaque. A plaque is defined as a yellowish greysubstance that adheres tenaciously to an intraoralhard surface. Each segment is scored from 0-3. Debris is scored as 0= no debris or stain present, 1= soft debriscovering less than 1/3rd of the tooth surface or presence of intrinsic stainswithout other debrispresent irrespective of surface area covered, 2 = soft debriscovering more than 1/3rd but not more than2/3rd of exposed tooth surface, 3 = soft debris covering more than 2/3rd of exposedtooth surface.
DI = debrisscore / number of segmentsscored
Calculus is scored as 0= no calculuspresent, 1= supragingival calculus covering notmore than 1/3rd of the exposed tooth surface, 2= supragingival calculuscovering more than 1/3rd but not more than 2/3rd of the exposed tooth surface or presence of individual flecks ofsub gingival calculus around the cervicalportion of the tooth or both, 3= supragingival calculus covering more than 2/3rd of the exposed tooth surface ora continuous heavy band of the subgingival calculusaround the cervical portion of thetooth or both.
CI =calculus score / number of segments scored OHI=CI+DI
OHI ranges from 0-12 and the higherthe score, pooreris the oral hygiene of the
patient. Patients with OHI of 6 or more will be includedin the study.
All patients whogive informed consent after screening eligibility for participation in the study will be examined by anexperienced dentist one day prior to surgery to assess and documentactive caries, the number of affected teeth and whetherperiodontal disease is present in the oral cavity. Active periodontaldisease, lost teeth and clinicalsigns of acute infection will also record. All the patients will be givenpreoperative antibiotic prophylaxis with inj. cefuroxime 750 mg iv along with the two postoperative doses. Theywill then be randomly divided into two groupsby random computer-generated numbers in sealed envelopes. Group A will receive 10 ml of chlorhexidine mouthwash0.2% (w/v) for oral rinse to be done for 10minutes while group B will receive 10ml of saline mouthwash for oral rinse for 10 minutes. Both the patient and theobserver will be blinded. A base line CBC will be collected in both the groups.The patients will be thenadministered general anaesthesia using standard anesthetic drugs followed by endotracheal intubation. Aftercompletion of surgery, extubation will be planned. Tracheal aspirate/broncho alveolar lavage for culture will becollected just prior to extubation alongwith post operative day 3, and 7 in whom culture will be positive or anysigns of infection present. CBC, Chest X Ray and CRPwill be sent on day 3
and day 7 for same. Core body temperature,incidence of sore throat, excessive bronchialsecretions, productive cough, abnormal broth sounds and need forsupplemental oxygen will be monitored till postoperative day 7. The diagnosis ofpostoperative pneumonia or LRTI willbe made based on the guidelines for the management of hospital acquiredpneumonia, which include:
• Purulent trachealsecretions and new and/or persistentinfiltrate on CXR, which is otherwise unexplained.
• Increased oxygen requirement
• Core temperature >38.3o C
• Blood leucocytes (>10,000/mm3) or leucopoenia (<4000/mm3).6
The diagnosis of postoperativepneumonia required the presence of all the criteria in the patients. URTI willbe defined as patients who have all the criteria for pneumonia, but do not have a new orprogressing infiltrate on chestradiograph.
Length of hospital stay and incidenceof surgical site infection will be noted.
Surgical siteinfection (SSI) will be defined as a wound defect in which infection is presentbeneath the subcutaneouslayers
iv. Ethics Review:Applied to institutional review board,KGMU,Lucknow for ethical clearance
v. Data collection & statistical analysis plan:Thedata obtained, will be analysed using Statistical Package for Social Sciences, version 21.0 or above. Patientswill be compared between cases and controls. Chi-square test/Fisher exact testwill be used.
10. Expected outcome:Based on the trend seen in preceding studies, we expectto find a positive co- relation betweenthe use of preoperative chlorhexidine mouthwash in preventing postoperative pulmonarycomplications. It has been observed that rinsingthe mouth with an antiseptic solution prevents growth of pathogenic bacteria.Thus, we hope to observethat preoperative mouthwashwith chlorhexidine in patientswith poor oral hygiene significantly prevents and/or reduces the incidenceof pneumonia and other associated respiratory complications particularly in those patientswho will be undergone generalanesthesia via endotracheal intubation.
11.Limitations of study:**11.****Limitations ofstudy**
• Study is single -centrewith small sample size.Large sample size is requiredto evaluate the influence of disease speciesand surgical procedures on postoperative respiratory complications ineach group
• Specificdeviation in case selection
• The effectof preoperative periodontal treatment on poor oral hygienepatients are not explored
• The effect of some factorssuch as age, sex, diabetes and smoking are not analyzed
**12.****Future plans based on expected outcome**
The effect of preoperative periodontal treatment on poor oralhygiene patient as well as on high risk surgeries can be better studied and analysed with better postoperative outcomes
**13.****Time line**
Total duration of project-2 years
1)Periodneeded for data collection-12 months 2)Periodneeded for follow up -6 months 3)Period neededfor data analysis-6 months
**14.****Institutional support**
Our institute has well developed general surgery departmentwith large number of patients inputfor surgery, having well equipped modular operation theatre and post anesthesiacare units. It has also microbiology department with advancelaboratories and equipments.
**15.****Budget**
Budget requirements (with detailed break-upand full justification):
| | | |
| --- | --- | --- |
| **1****st** **Year**
**2****nd** **Year**
|Consumables
2,00,000/
200,000/
|Contingencies
20,000/
20,000/
|Travel
NA
NA
|O v e r h e a d C h a rg e s
11,000/-
16000/-
|Total
2,31,000/-
2,36,000/-
**Grand Total:4,67,000/-**
REFERENCES1. Ploenes T, Pollok A,Jöckel K, Kampe S, DarwicheK, Taube C et al.The pathological oral cavity as apreventable source of postoperative pneumonia in thoracic surgery: a prospective observational study. Journal ofThoracic Disease. 2022;14(4):822-831.
2. ItoharaC, Matsuda Y, Sukegawa-Takahashi Y, Sukegawa S, Furuki Y, Kanno T. Relationship between Oral Health Statusand Postoperative Fever among Patients with Lung Cancer Treatedby Surgery: A Retrospective CohortStudy. Healthcare. 2020;8(4):405.
3. Ogawa M, Satomi-Kobayashi S, Yoshida N, Tsuboi Y, Komaki K, Nanba N et al. Impactof Oral Health Status on Postoperative Complications and Functional RecoveryAfter Cardiovascular Surgery.CJC Open. 2021;3(3):276-284.
4. BardiaA, Blitz D, Dai F, Hersey D, Jinadasa S, Tickoo M et al. Preoperative chlorhexidine mouthwash to reduce pneumonia after cardiac surgery:A systematic review andmeta-analysis. The Journal of Thoracic and Cardiovascular Surgery. 2019;158(4):1094-1100.
5. Soutome S,Yanamoto S, Funahara M, Hasegawa T, Komori T, Yamada S et al. Effect of perioperative oral care on prevention of postoperative pneumoniaassociated with esophageal cancer surgery. 2022.
6. Abbas K, Ahmad S. Outcomes followingthoracic surgery: the role of preoperative chlorhexidine mouthwash in the prevention of post-operative pneumonia. International Surgery Journal.2016;:921-926.
7. Lin Y, Xu L,Huang X, Jiang F, Li S, Lin F et al. Reduced occurrence of ventilator-associated pneumonia aftercardiac surgery using preoperative 0.2% chlorhexidineoral rinse: results from a single-centre single-blinded randomized trial.Journal of Hospital Infection. 2015;91(4):362-366.
8. NicolosiL, del Carmen Rubio M, Martinez C, Gonzalez N, Cruz M. Effect of Oral Hygiene and 0.12% Chlorhexidine Gluconate Oral Rinse in Preventing Ventilator-Associated Pneumonia After Cardiovascular Surgery.Respiratory Care. 2013;59(4):504-509.
9. Özçaka Ö, Başoğlu Ö, Buduneli N, Taşbakan M, Bacakoğlu F, Kinane D. Chlorhexidinedecreases the risk of ventilator-associated pneumonia in intensive care unit patients: a randomized clinicaltrial. Journal of Periodontal Research. 2012;47(5):584-592.
10. Bágyi K, HaczkuA, Márton I, Szabó J, Gáspár A, Andrási M et al. Role of pathogenic oral flora in postoperative pneumonia following brainsurgery. BMC Infectious Diseases. 2009;9(1).
11. HoustonS, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidinegluconate oral rinse in reducing prevalence ofnosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70.
12. DeRiso A,Ladowski J, Dillon T, Justice J, Peterson A. Chlorhexidine Gluconate 0.12% Oral Rinse Reduces the Incidence of Total Nosocomial Respiratory Infectionand Nonprophylactic Systemic Antibiotic Use in Patients Undergoing Heart Surgery. Chest. 1996;109(6):1556-1561.
•
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 289
Patients of ASA grade I/II, with poor oral hygiene (OHI more than 6), between 18-65 years of age posted for elective abdominal surgeries of less than 4 hours duration under general anaesthesia using endotracheal tube were included in the study.
- Patients undergoing laparoscopic surgeries, thoracic, cardiac and major bowel surgeries and patients in which supraglottic devices were used for GA were excluded from the study.
- Patients with active URTI/LRTI, COPD/asthma, active smokers, with alcohol abuse, diabetes mellitus, morbid obesity, any immune deficiency, heart insufficiency, those with known allergy to chlorhexidine, those on broad spectrum antibiotics and negative consent to participate in trial will also be excluded from the study.
- Patients who have not smoked for a year or longer will be classified as not having a smoking habit.
- Patients in whom prompt postoperative extubation could not be anticipated or neurological complications appeared, or those requiring re-intubation or re- exploration and those surgeries that extend beyond 4 hours will be dropped from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of pneumonia in postoperative period Baseline, 3 days and 7 days
- Secondary Outcome Measures
Name Time Method Duration of hospital stay after surgery 1 week, 2 week & 3 week
Trial Locations
- Locations (1)
King Georges Medical University
🇮🇳Lucknow, UTTAR PRADESH, India
King Georges Medical University🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Shefali GautamPrincipal investigator09450610553drshefaligautam@gmail.com