Overview

This trial is active, not recruiting.

Conditions post-operative pneumonia, lung cancer, esophageal cancer
Treatment intensive brushing regimen
Phase phase 2/phase 3
Sponsor Washington University School of Medicine
Start date September 2011
End date June 2017
Trial size 330 participants
Trial identifier NCT01446874, 201106336

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution Intubation with tapered polyurethane cuff endotracheal tube with subglottic drainage (Mallinckrodt™ Sealguard™ Evac Endotracheal Tube, Covidien, Mansfield, MA) intraoperatively and postoperatively as indicated, based upon standard clinical practice. 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.
intensive brushing regimen
Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution Intubation with tapered polyurethane cuff endotracheal tube with subglottic drainage (Mallinckrodt™ Sealguard™ Evac Endotracheal Tube, Covidien, Mansfield, MA) intraoperatively and postoperatively as indicated, based upon standard clinical practice. 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.
(No Intervention)
Continue brushing teeth as per current habits Continue mouthwash use as per current habits Intubation with standard PVC cuffed (polyvinyl chloride) endotracheal tube intraoperatively and postoperatively as indicated, based upon standard clinical practice.

Primary Outcomes

Measure
Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients
time frame: Within 30 days of surgery

Secondary Outcomes

Measure
Compliance with preoperative brushing and mouthwash protocol
time frame: Within 30 days of surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.