Prevention of Post-operative Pneumonia (POPP)
This study is currently recruiting participants.
Verified October 2011 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
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
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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;
- 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.
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
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
- 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).
- Patients undergoing esophageal resection.
Exclusion Criteria:
- Patients with ongoing symptomatic dental infections.
- Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
- Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
- Patients with a preexisting tracheostomy.
- Age<18
Contacts and Locations
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 Esophageal Diseases Esophageal Neoplasms Lung Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Chlorhexidine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Disinfectants |
ClinicalTrials.gov processed this record on June 17, 2013