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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Miriam Treggiari, University of Washington
ClinicalTrials.gov Identifier:
NCT01744483
First received: November 29, 2012
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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 Intervention
Ventilator-acquired Pneumonia
Device: PVC ETT
Device: PUC ETT
Device: PUC-CASS ETT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pilot Trial of Tubes to Prevent Ventilator-Associated Pneumonia (PreVent)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Tracheal bacterial colonization [ Time Frame: Between Day 2 and Day 4 of intubation ] [ Designated as safety issue: No ]
    The proportion 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. Proportions will be compared between the three study arms.

  • Feasibility [ Time Frame: Up to 2.5 years. ] [ Designated as safety issue: No ]
    The feasibility of performing a Phase III, randomized, controlled, single center trial comparing two tracheal tubes designed to prevent VAP with conventional tracheal tubes, in a mixed population of medical and surgical patients undergoing emergency tracheal intubation and mechanical ventilation will be assessed. Parameters will include validation of VAP definition, data algorithms and randomization procedures; assessment of compliance with the followup questionnaire; estimation of actual vs. expected recruitment proportions.


Secondary Outcome Measures:
  • Invasively Diagnosed VAP [ Time Frame: During mechanical ventilation (expected average of day 4 post-intubation) ] [ Designated as safety issue: No ]
    The proportion of patients who develop invasively-diagnosed VAP at any point during their hospital stay.

  • Cumulative Organ Dysfunction [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
    The Sequential Organ Failure Assessment (SOFA) Score will be compared between groups.

  • Length of Stay [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
    ICU and hospital length of stay will be compared between groups.

  • Mortality [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
    ICU and hospital mortality will be compared between groups.


Other Outcome Measures:
  • Duration of Mechanical Ventilation [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
    Duration of mechanical ventilation and ventilator-free days will be compared between groups.

  • Safety measures [ Time Frame: 48 hours and 2 months post-extubation (expected average of day 4 and day 62 post-intubation) ] [ Designated as safety issue: Yes ]
    In addition to tracking device-related adverse events and serious adverse events, the PreVent study will assess airway complications by various measures, including assessment for stridor, reintubation, dysphagia, and dysphonia within 48 hours of extubation, and assess long-term airway complications via telephone survey 2 months after extubation.


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744483

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Miriam Treggiari, MD University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Miriam Treggiari, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01744483     History of Changes
Other Study ID Numbers: 42230-A, 5R34HL105581-02
Study First Received: November 29, 2012
Last Updated: April 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Washington:
pneumonia
endotracheal intubation

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

ClinicalTrials.gov processed this record on September 16, 2014