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Prevention of Post-operative Pneumonia (POPP) (POPP)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01446874
First Posted: October 5, 2011
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine
September 30, 2011
October 5, 2011
November 1, 2016
September 2011
June 2017   (Final data collection date for primary outcome measure)
Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients [ Time Frame: Within 30 days of surgery ]

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.
Incidence of 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.
Complete list of historical versions of study NCT01446874 on ClinicalTrials.gov Archive Site
Compliance with preoperative brushing and mouthwash protocol [ Time Frame: Within 30 days of surgery ]
Subject compliance is measured by the subject completing a daily brushing diary, along with The Modified Morisky Medication/Intervention Adherence Scale and a Knowledge Questionnaire.
Compliance with preoperative brushing and mouthwash protocol
Subject compliance is measured by the subject completing a daily brushing diary, along with The Modified Morisky Medication/Intervention Adherence Scale and a Knowledge Questionnaire.
Not Provided
Not Provided
 
Prevention of Post-operative Pneumonia (POPP)
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Post-operative Pneumonia
  • Lung Cancer
  • Esophageal Cancer
Procedure: 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.

  • Active Comparator: Intensive Brushing Regimen
    1. Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
    2. 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.
    3. 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.
    Intervention: Procedure: Intensive Brushing Regimen
  • No Intervention: Regular brushing routine
    1. Continue brushing teeth as per current habits
    2. Continue mouthwash use as per current habits
    3. Intubation with standard PVC cuffed (polyvinyl chloride) endotracheal tube intraoperatively and postoperatively as indicated, based upon standard clinical practice.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
330
Not Provided
June 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01446874
201106336
Yes
Not Provided
Not Provided
Jennifer Bell, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Not Provided
Washington University School of Medicine
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP