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

• ClinicalTrials.gov Identifier: NCT01744483
• Recruitment Status: Completed
• First Posted: December 6, 2012
• Results First Posted: June 12, 2017
• Last Update Posted: October 26, 2017
• Sponsor: University of Washington
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Miriam Treggiari, University of Washington

Study Description

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	Phase
Ventilator-acquired Pneumonia	Device: PVC ETT; Device: PUC ETT; Device: PUC-CASS ETT	Not Applicable

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 Design

• 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
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: February 2016

Arms and Interventions

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	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 Name: Mallincrodt Evac Oral ETT, Seal Guard, Murphy Eye

Outcome Measures

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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Washington

Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Miriam Treggiari, MD; University of Washington

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Miriam Treggiari, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01744483
• Other Study ID Numbers: 42230; 5R34HL105581-02 ( U.S. NIH Grant/Contract )
• First Posted: December 6, 2012
• Results First Posted: June 12, 2017
• Last Update Posted: October 26, 2017
• Last Verified: September 2017

Keywords provided by Miriam Treggiari, University of Washington:

pneumonia; endotracheal intubation

Additional relevant MeSH terms:

Pneumonia; Pneumonia, Ventilator-Associated; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes