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Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia (PreVent2)

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ClinicalTrials.gov Identifier: NCT03705286
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Information provided by (Responsible Party):
Miriam Treggiari, Yale University

Tracking Information
First Submitted Date  ICMJE October 3, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE May 6, 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
  • Quality of life [ Time Frame: 6 months ]
    36-item Short-Form General Health Survey (Scores range from 0 - 100; Lower scores = more disability, higher scores = less disability)
  • Cognitive function [ Time Frame: 6 months ]
    Proportion of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
Airway related complications [ Time Frame: 6 months ]
Device-related adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 11, 2018)
  • Infection Related Ventilator-Associated Complications (IVACs) [ Time Frame: Up to 28 days ]
    Center for Disease Control defined IVACs
  • Ventilator-Associated Events (VAEs) [ Time Frame: Up to 28 days ]
    Center for Disease Control defined VAEs
  • Healthcare costs [ Time Frame: 6 months ]
    Healthcare resource utilization
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia
Official Title  ICMJE Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study
Brief Summary

Researchers are looking at two different types of breathing tubes to see if one is better than the other at preventing pneumonia. One of the tubes has a design features to prevent leakage of fluids from the mouth and the back of the throat into the lower airways and lungs. This is important since leakage of small amounts of fluid into the lungs may lead to pneumonia. The other 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 and improve quality of life and cognitive function, compared to the standard tube. The study will also look at the safety of the modified breathing tube, compared to the standard tube.

Detailed Description

The proposed study will be a randomized, controlled trial, conducted under Exception From Informed Consent (EFIC), comparing patients who undergo emergency tracheal intubation with one of two different endotracheal tubes (ETTs), one of which is designed to prevent ventilator-associated pneumonia (VAP): 1) An ETT fitted with a lumen to allow continuous aspiration of subglottic secretions and made with a polyurethane cuff (EVAC-PU-ETT); and 2) A standard ETT with a polyvinylchloride cuff (PVC-ETT). Approximately 1,074 adult patients requiring endotracheal intubation in the ED or hospital for acute respiratory distress or failure will be randomly assigned in an equal fashion to be intubated with one of the two ETTs (537 patients in each group). Because endotracheal intubation is performed in an emergency setting, the unit of randomization will be the intubation kits containing, in a concealed manner, one of the two types of ETT. The intubation kits are placed in areas where emergency intubation teams receive their intubation equipment supplies, primarily in the ICUs and in the emergency department. The study is designed to allow all patients requiring emergency intubation to be potentially eligible for enrollment to ensure the applicability of the study findings to a generalizable setting of patients receiving emergency intubation outside the operating room.

The trial primary aim is to determine if EVAC-PU-ETT is as safe as PVC-ETT and if long-term patient quality of life and cognitive function are better in PU-CASS-ETT, compared with PVC-ETT. The investigators will also monitor any device-related adverse events. Additional secondary endpoints include the incidence of infection-related ventilator associated conditions (IVAC) and ventilator associated events (VAEs), as defined by the Center for Disease Control, respiratory antibiotics use, incidence of "clinical" VAP, 28-day ventilator-free days, mean daily Sequential Organ Failure Assessment (SOFA) score, length of ICU and hospital stay, and mortality up to six months will serve to evaluate other clinical meaningful consequences resulting from the occurrence of VAP. Furthermore, the study will perform economic evaluation (cost-consequence approach) of quality of life, healthcare resource utilization and cost for hospitals. Primary and secondary endpoints will be compared between the PU-CASS-ETT and PVC-ETT groups, using an intention-to-treat approach.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Ventilator-acquired Pneumonia
Intervention  ICMJE
  • Device: EVAC-PU-ETT
    Placement of a EVAC-PU-ETT in the setting of emergent intubation.
    Other Name: Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy Eye
  • Device: PVC-ETT
    Placement of a PVC-ETT in the setting of emergent intubation.
    Other Name: Shiley™ Cuffed Basic Endotracheal Tube
Study Arms  ICMJE
  • Active Comparator: PVC-ETT
    Polyvinylchloride endotracheal tube
    Intervention: Device: EVAC-PU-ETT
  • Experimental: EVAC-PU-ETT
    Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube
    Intervention: Device: PVC-ETT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
1074
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. ≥18 years of age
  2. Requiring emergency endotracheal intubation in the ED or in-hospital for acute respiratory distress or failure
  3. A study intubation kit containing the study ID number must have been used for the emergency intubation
  4. Admitted to the ICU and receiving mechanical ventilation

Exclusion Criteria:

  1. Patients electively intubated in the operating room whether or not they require subsequent ICU admission
  2. Use of a non-study designated intubation kit (such as nasal intubation, tracheotomy, intubation occurring at a location not supplied with the study intubation kits)
  3. Patients with permanent tracheostomy
  4. Protected populations including children (age <18 years), pregnant women, or prisoners
  5. Evidence of unwillingness to participate in a research study as documented in the patient's electronic health record, or at the time of intubation if there is opportunity to read the opt-out script.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Miriam M Treggiari, MD, PhD, MPH 1-888-202-5977 yarn@yale.edu
Contact: Michael Kampp micheal.kampp@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03705286
Other Study ID Numbers  ICMJE 2000027877
1R61HL138650-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Miriam Treggiari, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Miriam M Treggiari, MD, PhD, MPH Yale University
PRS Account Yale University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP