Endotracheal Tubes for Prevention of Ventilator-associated Pneumonia (PreVent)

Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-acquired Pneumonia
• Intervention / Treatment: Device: PVC ETT; Device: PUC ETT; Device: PUC-CASS ETT

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PVC ETT; Polyvinylchloride cuff endotracheal tube	Device: PVC ETT; Placement of a PVC-cuffed ETT in the setting of emergent intubation.; Other Names: Mallinckrodt Hi-Lo Oral/Nasal ETT Cuffed. Murphy Eye.
EXPERIMENTAL: PUC ETT; Polyurethane cuff endotracheal tube	Device: PUC ETT; Placement of a PUC-cuffed ETT in the setting of emergent intubation.; Other Names: Mallinckrodt Seal Guard, oral/nasal ETT.
EXPERIMENTAL: PUC-CASS ETT; Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube	Device: PUC-CASS ETT; Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.; Other Names: Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Tracheal Bacterial Colonization	The percentage of patients with quantitative culture growth from tracheal aspirate specimens of >1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.	Tracheal colonization by Day 4 or extubation

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (ESTIMATE): December 6, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: endotracheal intubation; pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 42230; 5R34HL105581-02 (NIH)