Clinical trial NCT01446874: Prevention of Post-operative Pneumonia (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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Post-operative Pneumonia
Lung Cancer
Esophageal Cancer
Keywords: Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients
timeFrame: Within 30 days of surgery
measure: Adherence to the Pre-operative Toothbrushing Regimen
timeFrame: Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)
Secondary outcomes:
measure: Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary
timeFrame: Within 30 days of surgery (comparing pre-op and post-op)
measure: Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire
timeFrame: Within 30 days of surgery
measure: Perioperative Mortality
timeFrame: Within 30 days of surgery
measure: Postoperative Respiratory Failure
timeFrame: Within 30 days of surgery
measure: Incidence of Fever
timeFrame: Within 24 hours of surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Varun Puri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Semenkovich TR, Frederiksen C, Hudson JL, Subramanian M, Kollef MH, Patterson GA, Kreisel D, Meyers BF, Kozower BD, Puri V. Postoperative Pneumonia Prevention in Pulmonary Resections: A Feasibility Pilot Study. Ann Thorac Surg. 2019 Jan;107(1):262-270. doi: 10.1016/j.athoracsur.2018.08.008. Epub 2018 Oct 3.