N/A N=117 Randomized Double-blind Prevention

Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia

Ventilator-acquired Pneumonia

Bottom Line

View on ClinicalTrials.gov: NCT01744483 ↗

Enrolled (actual)

117

Serious AEs

22.6%

Results posted

Jun 2017

Primary outcome: Primary: Percentage of Patients With Tracheal Bacterial Colonization — 8; 7; 9 percentage of tracheal colonization

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PVC ETT (Device); PUC ETT (Device); PUC-CASS ETT (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Tracheal Bacterial Colonization	8; 7; 9	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age 18 years or older;
Emergency intubation with a study device either in the field by Medic One, (the Seattle Fire Department program that provides basic and advanced life support services to the city) or at HMC;
Absence of out-of-hospital cardiac arrest;
Absence of major burns, penetrating trauma or absence any major trauma with systolic blood pressure < 90 mmHg at the time of tracheal intubation.

Exclusion Criteria

Use of a non-study designated intubation device (such as nasal intubation, tracheostomy, intubation in the operating room, intubation outside the study network such as occurring in an outside hospital or by other emergency response providers);
Patients with permanent tracheostomy;
Federally protected populations: Children (age <18 years), pregnant women, and prisoners.

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Data sourced from ClinicalTrials.gov (NCT01744483). 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.