Phase 2
N=1,068
Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia
Ventilator-acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT03705286 ↗Enrolled (actual)
1,068
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Quality of Life - 36-item Short-Form General Health Survey — 40.5; 40.0; 48.9; 45.9 score on a scale — p=0.78
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EVAC-PU-ETT (Device); PVC-ETT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life - 36-item Short-Form General Health Survey |
40.5; 40.0; 48.9; 45.9 | 0.78 |
| PRIMARY Cognitive Function |
54; 70 | 0.05 |
| SECONDARY Airway Related Complications |
49; 71 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- Requiring emergency endotracheal intubation in the ED or in-hospital for acute respiratory distress or failure
- A study intubation kit containing the study ID number must have been used for the emergency intubation
- Admitted to the ICU and receiving mechanical ventilation
Exclusion Criteria
- Patients electively intubated in the operating room whether or not they require subsequent ICU admission
- Use of a non-study designated intubation kit (such as nasal intubation, tracheotomy, intubation occurring at a location not supplied with the study intubation kits)
- Patients with permanent tracheostomy
- Protected populations including children (age <18 years), pregnant women, or prisoners
- Evidence of unwillingness to participate in a research study as documented in the patient's electronic health record, or at the time of intubation if there is opportunity to read the opt-out script.
Data sourced from ClinicalTrials.gov (NCT03705286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.