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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744483
Recruitment Status : Completed
First Posted : December 6, 2012
Results First Posted : June 12, 2017
Last Update Posted : October 26, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Miriam Treggiari, University of Washington

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.

Condition or disease Intervention/treatment
Ventilator-acquired Pneumonia 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  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)
Study Start Date : December 2012
Primary Completion Date : October 2015
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 Name: 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 Name: Mallinckrodt Seal Guard, oral/nasal ETT.
Experimental: PUC-CASS ETT
Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube
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 Name: Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye

Primary Outcome Measures :
  1. Percentage of Patients With Tracheal Bacterial Colonization [ Time Frame: Tracheal colonization by Day 4 or extubation ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744483

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Miriam Treggiari, MD University of Washington

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Miriam Treggiari, Professor, University of Washington Identifier: NCT01744483     History of Changes
Other Study ID Numbers: 42230
5R34HL105581-02 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2012    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: October 26, 2017
Last Verified: September 2017

Keywords provided by Miriam Treggiari, University of Washington:
endotracheal intubation

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury