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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

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.


Condition or disease Intervention/treatment Phase
Ventilator-acquired Pneumonia Device: EVAC-PU-ETT Device: PVC-ETT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1074 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: PVC-ETT
Polyvinylchloride endotracheal tube
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

Experimental: EVAC-PU-ETT
Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube
Device: PVC-ETT
Placement of a PVC-ETT in the setting of emergent intubation.
Other Name: Shiley™ Cuffed Basic Endotracheal Tube




Primary Outcome Measures :
  1. 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)

  2. Cognitive function [ Time Frame: 6 months ]
    Proportion of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set


Secondary Outcome Measures :
  1. Airway related complications [ Time Frame: 6 months ]
    Device-related adverse events


Other Outcome Measures:
  1. Infection Related Ventilator-Associated Complications (IVACs) [ Time Frame: Up to 28 days ]
    Center for Disease Control defined IVACs

  2. Ventilator-Associated Events (VAEs) [ Time Frame: Up to 28 days ]
    Center for Disease Control defined VAEs

  3. Healthcare costs [ Time Frame: 6 months ]
    Healthcare resource utilization



Information from the National Library of Medicine

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

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.

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 ClinicalTrials.gov identifier (NCT number): NCT03705286


Contacts
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Contact: Miriam M Treggiari, MD, PhD, MPH 1-888-202-5977 yarn@yale.edu
Contact: Michael Kampp micheal.kampp@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Miriam Treggiari, MD       yarn@yale.edu   
Contact: Michael Kampp         
Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Investigators
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Principal Investigator: Miriam M Treggiari, MD, PhD, MPH Yale University
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Responsible Party: Miriam Treggiari, Vice Chair of Clinical Research, Anesthesiology, Yale University
ClinicalTrials.gov Identifier: NCT03705286    
Other Study ID Numbers: 2000027877
1R61HL138650-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Miriam Treggiari, Yale University:
Pneumonia
Endotracheal intubation
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection