OCCURRENCE OF BREATHING COMPLICATIONS AFTER CANCER SURGERIES

Not yet recruiting

• Conditions: Patients undergoing oncocological surgeries including head and neck surgeries, laparotomy, thoracotomy, joint dislocation and amputations under general or regional anaesthesia

• Registration Number: CTRI/2017/08/009395
• Lead Sponsor: AIIMS

Brief Summary

**Introduction**

Thepostoperative pulmonary complication (PPC) includes almost any complicationaffecting the respiratory system after anaesthesia and surgery. Thecomplications are defined heterogeneously in literature, occur commonly, havemajor adverse effects on patients and are difficult to predict. 1There are various definitions available in literature:

Ø  Respiratory complications that occur within 48-72 hoursfollowing surgery 2

Ø  Conditions affecting the respiratory tract that can adverselyinfluence the clinical course of the patient after surgery 3

Ø  Any pulmonary abnormality occurring in the postoperativeperiod that produces identifiable disease or dysfunction that is clinicallysignificant and adversely affects the clinical course.

The incidence of PPC varies widelyfrom 5 to 40 %. This is mainly due to lack of uniformity about the inclusion ofmedical conditions as PPC, the population studied, the postoperative time framestudied, the type of postoperative care provided and outcome measures utilized.Some of the conditions included are atelectasis, pneumonia, bronchospasm, exacerbationof previous lung disease, pulmonary collapse due to mucus plugging of airways.Respiratory failure with ventilatory support > 48 hrs, acute lung injury (ALI)including aspiration pneumonitis, Transfusion related acute lung injury (TRALI),and acute respiratory distress syndrome (ARDS) and pulmonary embolism.4 Thefactors affecting the development of PPC are related to prior health status ofpatient and effects of anaesthesia and surgical trauma. The interaction betweenthese factors determines risk. Usually risk factors are related to the surgicalprocedure, anaesthesia technique including perioperative analgesia and patientrelated including preoperative comorbidities. 5 Inadequate paincontrol in postoperative period may lead to increased risk of Postoperativepulmonary complications.

The risk factors include patientrelated like advanced age, body mass index (BMI) , American Society of Anesthesiologist(ASA) physical status, comorbidities especially cardiac and pulmonary diseases, impaired liver and renal profile , low hemoglobin , preoperative drug uselike steroids and history of smoking. The intraoperative factors include siteof surgery (upper abdominal and thoracic have higher incidence of PPC ),duration of surgery, type of surgery emergency or elective, re-operation ,intraoperative blood loss, amount of fluids given , intraoperative and postoperativeanalgesia.The incidence of PPC can be reduced by risk reductionstrategies, performing short duration or minimally invasive surgery and use ofanaesthetic technique of combined regional with general anaesthesia. Atelectasisis the main cause of PPCs. Atelectasis can be prevented or treated by adequateanalgesia, incentive spirometry, deep breathing exercises, continuous positiveairway pressure, mobilization of secretions and early ambulation. 4

This observational prospective studywas designed to see the incidence and risk factors for PPC in major oncologicalsurgeries in tertiary care institute. Withthis background the present study will be done to observe the incidence of PPCand associated risk factorsin major oncological surgeries.

**Aims and Objectives**

1    To determine the incidence of postoperativepulmonary complications in major oncological surgeries.

2   To predict the relation between occurrenceof postoperative pulmonary complications and associated risk factors.

**Material and Methods**

***Studydesign***: This observational prospectivestudy will be conducted in Department of Onco-Anaesthesia and Palliative Medicine , DRBRAIRCH, AIIMS ,New Delhi after approval from institutional ethical committee.

***Methods***:

All the patients undergoing majorelective or emergency oncological surgeries including head and neck surgeries, laparotomy, thoracotomy, jointdislocation and amputations under general or regional anaesthesia will berecruited in the study. Patients will be explained about the study protocol andwritten informed consent will be taken to participate in the study.

The patient related information willbe recorded on a standard performa. Patients demographic profile includingweight, body mass index (BMI), comorbidities (including pulmonary and cardiacconditions), ASA physical status, functional capacity, history of smoking,history of previous chemotherapy/radiotherapy and any drug history would berecorded. Patient’s investigations including complete blood count, liverfunction test, renal function test, chest x-ray, electrocardiogram, and Echocardiograph/ pulmonary function test (PFT) if done would be recorded from patientshospital record. These tests are routine preoperative tests and are recorded inpatient’s hospital records.

Anaesthesia and perioperative carewill be provided as per standard by the concerned anaesthesiologist. Intraoperativedetails like type and duration of surgery, type of anaesthesia and analgesiaespecially use of regional blocks, airway management techniques, use of nasogastrictube, intraoperative blood loss, volume of fluid and blood replacement and anyintraoperative complications (respiratory, cardiac etc) would be recorded.

Thepatients would be followed for postoperative pulmonary complications at Day 0,Day 1, Day 2, Day 5 and or at the time of discharge. The patients will also befollowed for postoperative analgesia by NRS (Numeric Rating Scale) on a scaleof 0 – 10 on these days. The minimum and maximum NRS over 24 hrs would berecorded.  The patients would be assessedfor below mentioned PPC based on clinical or radiological findings as per theroutine care. The radiological findings will be assessed in the background ofclinical assessment and any discrepancy with regards to radiological findingswill be ascertained by radiologists. The data will also be collected fromclinical follow up, nursing charts, and electronic record of the patients forthe rest of the days. The postoperative management of patients would be done accordingto the discretion of the anaesthesiologist, surgical oncologists andintensivist. Pulmonary complications would be defined according to standarddefinitions. Pulmonary complications include:

Ø  **Pneumonia / Respiratory infection**: Two or more of the following for > 48 hrs: new cough /sputum production, physical findings compatible with pneumonia, fever > 38ºC , and new infiltrate on chest x-ray . 14

Ø  **Respiratory Failure**: Needfor postoperative mechanical ventilation>48 hrs . Unplanned re-intubationbecause of respiratory distress, hypoxia, hypercarbia, or respiratory acidosiswithin 30 days of surgery or requiring NIV. 15

Ø  **Bronchospasm** :Newly detected expiratory wheeze treated with bronchodilators.16

Ø  **Respiratory insufficiency**:Postoperative hypoxemia (SpO2 < 95 ) on room air and respiratoryinsufficiency requiring prolonged oxygen administration by nasal canula or facemask for > 1 day after surgery 6

Ø  **Atelectasis**: Radiologicalevidence on chest x-ray of collapse of lung segment which may be mild collapseto severe leading to lung opacification with mediastinal shift , hilum orhemidiaphragm shift towards effected area , with compensatory hyperinflation inadjacent nonatelectatic lung .16

Ø  **ARDS** : According toBerlin definition of ARDS 17

·        Timing  : Within 1 week of a known clinical insult ornew or worsening respiratory symptoms

·        Chest imaging: Bilateral opacities — not fullyexplained by effusions, lobar/lung collapse, or nodules

·        Origin of edema : Respiratory failure not fully explained by cardiac failure or fluidoverload.Need objective assessment (e.g., echocardiography) to exclude hydrostaticedema if no risk factor present.

·        Oxygenation:

·        Mild 200 mmHg < PaO2/FIO2 ≤300 mmHg with PEEP orCPAP ≥5 cmH2Oc

·        Moderate100 mmHg <PaO2/FIO2 ≤200 mmHg with PEEP ≥5 cmH2O

·        SeverePaO2/FIO2 ≤100 mmHg with PEEP ≥5 cmH2O

Ø  **TRALI** : TRALI has been defined by both NationalHeart , Lung and Blood Institute (NHLBI ) working group as well as CanadianConsensus Conference , as new acute lung injury( ALI )/ Acute respiratorydistress syndrome occurring during or within six hours after blood productadministration . When a clear temporal relationship to an alternative riskfactor for ALI/ ARDS coexists, a formal diagnosis of TRALI cannot be made.18

Ø  **Pneumothorax**: Any amount ofair in the pleural space with no vascular bed surrounding the visceral pleuraas confirmed on chest x-ray. Pneumothorax requiring thoracocentesis or ICD.19

Ø  **Pleural effusion** : Chest X Ray with blunting of costophrenicangle, loss of sharp silhouette of the ipsilateral diaphragm in uprightposition , displacement of anatomical structures 20

Ø  **Pulmonaryembolism** : Symptoms and signs suggestive ofpulmonary embolism such as dyspnea, chest pain , tachycardia, tachypnea leadingto suspected diagnosis of pulmonary embolism by Wells criteria 21

·        Symptoms of DVT (3 points)

·        No alternative diagnosis better explains theillness (3 points)

·        Tachycardia with pulse > 100 (1.5 points)

·        Immobilization (>= 3 days) or surgery in theprevious four weeks (1.5 points)

·        Prior history of DVT or pulmonary embolism (1.5points)

·        Presence of hemoptysis (1 point)

·        Presence of malignancy ( 1 point )

o  Score > 4 PE likely

o  Score < 4 PE unlikely

Ø  **Pulmonary edema**: Symptoms andsigns suggestive of fluid overload or congestive heart failure such as dyspnea, orthopnea , PND , hemoptysis , raised JVP , peripheral edema, B/Lcrepitations and presence of third heart sound. 22

Ø  **Bronchopleural Fistula**: Can bediagnosed clinically and radiologically. Clinical features include fever withserosanguinous or purulent sputum . The diagnosis must be suspected when thereis a persistent postoperative air leak (immediate postoperative period) or whenthere is a new or increasing air fluid level . Radiological features suggestiveof presence or the development of a BPF include (1) steady increase in intrapleuralair space (2 ) appearance of a new air fluid level (3 ) changes in an alreadypresent air fluid level (4) development of tension pneumothorax . The diagnosismay be further confimed by fibreoptic bronchoscopy 23

Any mortality during thestudy period will also be recorded. The possible reason based on clinicalassessment or with available investigation and imaging will be assessed andrecorded.

**Statistical Analysis:**

***Samplesize:***

After extensive review literaturesearch, we found incidence of PPC in the range of 5% to 40%. Considering 40%incidence with 5% allowable error, the required sample size of our study is385.

To describe patientscharacteristics like demographic parameters , the data will be summarized andanalysed using STATA (version 14) software. Data will be expressed as mean +/-SD or number and percentage as appropriate for qualitative and quantitative variables.Data will be tested for normality using the Kolmogorov – Smirnov test .T Testwill be used to compare the parametric values, whereas the Mann – Whitney Utest will be performed to compare the nonparametric values . For comparision ofcategorial  data  , the chi- square test / Fischer exact testwill be used. Multiple regression analysis will be performed with use oflogistic regression. A stepwise approach will be used to estimate the risk andrelative 95 % confidence interval for each covariate. A value of p less than0.05 will be considered to represent statistical significance of the study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-08-16
• Study Start: 2017-08-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

All the patients undergoing major elective or emergency oncological surgeries including head and neck surgeries, laparotomy, thoracotomy, joint dislocation and amputations under general or regional anaesthesia will be recruited in the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of postoperative pulmonary complications in major oncological surgeries.	DAY 0,1,2,5 AND AT DISCHARGE

Secondary Outcome Measures

Name	Time	Method
predict the relation between occurrence of postoperative pulmonary complications and associated risk factors	Day 0, Day 1, Day 2, Day 5 and or at the time of discharge after the surgery

Trial Locations

Locations (1)

AIIMS; 🇮🇳 South, DELHI, India

AIIMS

🇮🇳South, DELHI, India

DR RAKESH GARG

Principal investigator

9810394950

drrgarg@hotmail.com