Prevention of Post-operative Pneumonia (POPP)

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Postoperative Pneumonia (POPP Study): A Study to Evaluate the Use of a Prophylactic Clinical Strategy to Prevent Postoperative Pneumonia in Patients Undergoing Thoracic Surgery

Conditions
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Post-operative Pneumonia, Lung Cancer, Esophageal Cancer

Intervention / Treatment
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* Drug: 0.12% chlorhexidine solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-operative brushing (Pilot Portion)<br>-Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution | Drug: 0.12% chlorhexidine solution<br>* Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.<br>|
| Experimental: Pre-operative & Post-Operative Brushing (Esophageal Resection)<br>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. | Drug: 0.12% chlorhexidine solution<br>* Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.<br>|
| Experimental: Pre-operative & Post-Operative Brushing (Lung Resection)<br>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. | Drug: 0.12% chlorhexidine solution<br>* Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients | Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery; Fever (Temperature >38.2 C) Leucocytosis (WBC>12,000/cu mm) New infiltrate on chest X-ray Positive sputum or bronchial culture Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database. | Within 30 days of surgery | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire | Within 30 days of surgery | 
| Perioperative Mortality |  | Within 30 days of surgery | 
| Postoperative Respiratory Failure | Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy | Within 30 days of surgery | 
| Incidence of Fever |  | Within 24 hours of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer