Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia (PreVent)
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|ClinicalTrials.gov Identifier: NCT01744483|
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : June 12, 2017
Last Update Posted : October 26, 2017
Researchers are looking at three different types of breathing tubes to see if any of them are better at preventing pneumonia than the others. Two of the tubes have design features to prevent leakage of fluids from the mouth and throat into the lungs. This is importance, since leakage of small amounts of fluid into the lungs may lead to pneumonia. The third tube is the standard tube used at most hospitals.
The hypothesis is that the use of a breathing tube that reduces fluid leakage into the lungs will reduce the risk of developing pneumonia, compared to the standard tube. The study will also look at the safety of the modified breathing tubes, compared to the standard tube.
This study is a small, "pilot" study that will determine if it is possible to perform a larger study that will provide more certain results.
|Condition or disease||Intervention/treatment||Phase|
|Ventilator-acquired Pneumonia||Device: PVC ETT Device: PUC ETT Device: PUC-CASS ETT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||February 2016|
Active Comparator: PVC ETT
Polyvinylchloride cuff endotracheal tube
Device: PVC ETT
Placement of a PVC-cuffed ETT in the setting of emergent intubation.
Other Name: Mallinckrodt Hi-Lo Oral/Nasal ETT Cuffed. Murphy Eye.
Experimental: PUC ETT
Polyurethane cuff endotracheal tube
Device: PUC ETT
Placement of a PUC-cuffed ETT in the setting of emergent intubation.
Other Name: Mallinckrodt Seal Guard, oral/nasal ETT.
Experimental: PUC-CASS ETT
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
Device: PUC-CASS ETT
Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
Other Name: Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye
- Percentage of Patients With Tracheal Bacterial Colonization [ Time Frame: Tracheal colonization by Day 4 or extubation ]The percentage of patients with quantitative culture growth from tracheal aspirate specimens of >1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744483
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Miriam Treggiari, MD||University of Washington|