Overview

This trial is active, not recruiting.

Condition ventilator-acquired pneumonia
Treatments pvc ett, puc ett, puc-cass ett
Sponsor University of Washington
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date December 2012
End date December 2014
Trial size 120 participants
Trial identifier NCT01744483, 42230-A, 5R34HL105581-02

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Polyvinylchloride cuff endotracheal tube
pvc ett Mallinckrodt Hi-Lo Oral/Nasal ETT Cuffed. Murphy Eye.
Placement of a PVC-cuffed ETT in the setting of emergent intubation.
(Experimental)
Polyurethane cuff endotracheal tube
puc ett Mallinckrodt Seal Guard, oral/nasal ETT.
Placement of a PUC-cuffed ETT in the setting of emergent intubation.
(Experimental)
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
puc-cass ett Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye
Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.

Primary Outcomes

Measure
Tracheal bacterial colonization
time frame: Between Day 2 and Day 4 of intubation
Feasibility
time frame: Up to 2.5 years.

Secondary Outcomes

Measure
Invasively Diagnosed VAP
time frame: During mechanical ventilation (expected average of day 4 post-intubation)
Cumulative Organ Dysfunction
time frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days.
Length of Stay
time frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days.
Mortality
time frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age 18 years or older; 2. 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; 3. Absence of out-of-hospital cardiac arrest; 4. 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: 1. 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); 2. Patients with permanent tracheostomy; 3. Federally protected populations: Children (age <18 years), pregnant women, and prisoners.

Additional Information

Official title Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)
Principal investigator Miriam Treggiari, MD
Description The objective of this pilot study is provide data for planning and to establish the feasibility of performing a large, randomized, comparative effectiveness trial of two specially designed airway tubes (endotracheal tubes; ETTs) for the prevention of ventilator-associated pneumonia (VAP). Modification of the material and design of the ETT cuff that is positioned in the trachea, and/or continuous aspiration of subglottic secretions through an extra port positioned between the tube cuff and the vocal chords may prevent leakage of contaminated secretions around the cuff and thereby reduce the risk of VAP. The investigators are planning a phase III, randomized, controlled trial comparing the effectiveness of a polyurethane-cuffed endotracheal tube (PUC-ETT), a polyurethane-cuffed tube that also allows continuous aspiration of subglottic secretions (PUC-CASS-ETT), and a conventional, polyvinylchloride-cuffed endotracheal tube (PVC-ETT) in mechanically ventilated patients with respiratory failure. Prior to initiating the Phase III trial, a smaller pilot study is necessary in order to establish feasibility and to gather data on endpoints in order to establish enrollment rates and project sample size for the definitive trial. For the purposes of planning, a surrogate for VAP, bacterial colonization of the trachea will be assessed from daily quantitative cultures to allow estimation of effect size for the two study devices. VAP will be diagnosed using objective criteria, based on cultures from bronchoalveolar lavage. The safety profile of the tubes will be evaluated using a multi-faceted approach, including short-term objective measures of laryngeal dysfunction and long-term subjective and objective assessment of upper airway problems via phone interview post-hospital discharge, and recording of device-related adverse events.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Washington.