Prevention of Post-operative Pneumonia (POPP)

Phase 3TerminatedNCT01446874

Washington University School of Medicine150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Post-operative Pneumonia Lung Cancer Esophageal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy) 2. 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). 3. Patients undergoing esophageal resection. Exclusion Criteria: 1. Patients with ongoing symptomatic dental infections. 2. Patients with recent/ongoing pneumonia (\<15 days from initial surgical patient evaluation). 3. Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery. 4. Patients with a preexisting tracheostomy. 5. Age\<18 6. Patients with an allergy to Peridex/chlorhexidine solution

Outcomes

Primary Outcomes

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; 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.

Time frame: Within 30 days of surgery

Adherence to the Pre-operative Toothbrushing Regimen

Time frame: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)

Secondary Outcomes

Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary

Time frame: 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

Time frame: Within 30 days of surgery

Perioperative Mortality

Time frame: Within 30 days of surgery

Postoperative Respiratory Failure

Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy

Time frame: Within 30 days of surgery

Incidence of Fever

Time frame: Within 24 hours of surgery

Prevention of Post-operative Pneumonia (POPP)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes