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Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia

NCT03705286 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1074

Last updated 2024-09-24

Study results available
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Summary

Researchers are looking at two different types of breathing tubes to see if one is better than the other at preventing pneumonia. One of the tubes has a design features to prevent leakage of fluids from the mouth and the back of the throat into the lower airways and lungs. This is important since leakage of small amounts of fluid into the lungs may lead to pneumonia. The other 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 and improve quality of life and cognitive function, compared to the standard tube. The study will also look at the safety of the modified breathing tube, compared to the standard tube.

Conditions

  • Ventilator-acquired Pneumonia

Interventions

DEVICE

EVAC-PU-ETT

Placement of a EVAC-PU-ETT in the setting of emergent intubation.

DEVICE

PVC-ETT

Placement of a PVC-ETT in the setting of emergent intubation.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Oregon Health and Science University

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Miriam M Treggiari, MD, PhD, MPH · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2023-02-23
Completion
2023-02-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705286 on ClinicalTrials.gov