Clinical trial NCT01744483: Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia
Official title: Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-acquired Pneumonia
Keywords: pneumonia
endotracheal intubation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-12-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Tracheal Bacterial Colonization
timeFrame: Tracheal colonization by Day 4 or extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Miriam Treggiari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deem S, Yanez D, Sissons-Ross L, Broeckel JA, Daniel S, Treggiari M. Randomized Pilot Trial of Two Modified Endotracheal Tubes To Prevent Ventilator-associated Pneumonia. Ann Am Thorac Soc. 2016 Jan;13(1):72-80. doi: 10.1513/AnnalsATS.201506-346OC.