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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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Post-operative Pneumonia, Lung Cancer, Esophageal Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients

Outcome Description:

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.

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

201106336

NCT ID:

NCT01446874

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Post-operative Pneumonia
  • Lung Cancer
  • Esophageal Cancer
  • Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Pneumonia

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110