Prevention of Post-operative Pneumonia (POPP)
- Conditions
- Esophageal CancerPost-operative PneumoniaLung Cancer
- Interventions
- Registration Number
- NCT01446874
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
Postoperative pneumonia is a major complication in patients undergoing thoracic surgery. It leads to considerable morbidity and contributes to perioperative morbidity. There is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (VAP) in mechanically ventilated patients. This study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
- Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
- Patients with poor lung function (FEV1% <50% or DLCO<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
- Patients undergoing esophageal resection.
- Patients with ongoing symptomatic dental infections.
- Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
- Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
- Patients with a preexisting tracheostomy.
- Age<18
- Patients with an allergy to Peridex/chlorhexidine solution
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre-operative & Post-Operative Brushing (Esophageal Resection) 0.12% chlorhexidine solution * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution * The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group. Pre-operative & Post-Operative Brushing (Lung Resection) 0.12% chlorhexidine solution * Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution * The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group. Pre-operative brushing (Pilot Portion) 0.12% chlorhexidine solution -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
- Primary Outcome Measures
Name Time Method Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients Within 30 days of surgery Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery;
1. Fever (Temperature \>38.2 C)
2. Leucocytosis (WBC\>12,000/cu mm)
3. New infiltrate on chest X-ray
4. Positive sputum or bronchial culture
5. Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database.Adherence to the Pre-operative Toothbrushing Regimen Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
- Secondary Outcome Measures
Name Time Method Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary Within 30 days of surgery (comparing pre-op and post-op) Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire Within 30 days of surgery Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
Perioperative Mortality Within 30 days of surgery Postoperative Respiratory Failure Within 30 days of surgery Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy
Incidence of Fever Within 24 hours of surgery
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States