Prevention of Post-operative Pneumonia (POPP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01446874
First received: September 30, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Post-operative Pneumonia
Lung Cancer
Esophageal Cancer
Procedure: Intensive Brushing Regimen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Compliance with preoperative brushing and mouthwash protocol [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 330
Study Start Date: September 2011
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446874

Contacts
Contact: Jennifer M Bell, RN, BSN 314-747-6969 bellj@wudosis.wustl.edu
Contact: Joanne F Musick, RN, BSN 314-747-0707 musickj@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jennifer M Bell, RN, BSN    314-747-6969    bellj@wudosis.wustl.edu   
Contact: Joanne F Musick, RN, BSN    314-747-0707    musickj@wudosis.wustl.edu   
Principal Investigator: Varun Puri, MD         
Sponsors and Collaborators
Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Jennifer Bell, Manager of Research Operations, Cardiothoracic Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01446874     History of Changes
Other Study ID Numbers: 201106336
Study First Received: September 30, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer

Additional relevant MeSH terms:
Pneumonia
Lung Neoplasms
Esophageal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants

ClinicalTrials.gov processed this record on October 19, 2014