Prevention of Post-operative Pneumonia (POPP)

Lung Cancer Clinical Trial

— POPP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01446874
• Other study ID #: 201106336
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 22, 2011
• Est. completion date: December 13, 2015

Study information

• Verified date: October 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 13, 2015
• Est. primary completion date: December 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Lung Cancer
• Pneumonia
• Post-operative Pneumonia

Intervention

Drug:
• 0.12% chlorhexidine solution
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adherence to the Pre-operative Toothbrushing Regimen		Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
Secondary	Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary		Within 30 days of surgery (comparing pre-op and post-op)
Secondary	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
Secondary	Perioperative Mortality		Within 30 days of surgery
Secondary	Postoperative Respiratory Failure	Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy	Within 30 days of surgery
Secondary	Incidence of Fever		Within 24 hours of surgery

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine