Prevention of Post-operative Pneumonia (POPP) (POPP)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Jennifer Bell, Washington University School of Medicine
First received: September 30, 2011
Last updated: December 16, 2015
Last verified: December 2015
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.
Procedure: Intensive Brushing Regimen
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Incidence of postoperative pneumonia in the two groups: lung cancer resection patients and esophageal resection patients [ Time Frame: Within 30 days of surgery ] [ 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:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2016 (Final data collection date for primary outcome measure)
Active Comparator: 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.
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
- Continue brushing teeth as per current habits
- Continue mouthwash use as per current habits
- Intubation with standard PVC cuffed (polyvinyl chloride) endotracheal tube intraoperatively and postoperatively as indicated, based upon standard clinical practice.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|Washington University School of Medicine
|St. Louis, Missouri, United States, 63110 |
Washington University School of Medicine
||Jennifer Bell, Manager of Research Operations, Cardiothoracic Surgery, Washington University School of Medicine
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 30, 2011
||December 16, 2015
||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:
ClinicalTrials.gov processed this record on July 26, 2016
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Infections
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Anti-Infective Agents, Local