Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia (PreVent2)

Randomized Trial of Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia - PreVent 2 Study

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.

Study Overview

• Status: Completed
• Conditions: Ventilator-acquired Pneumonia
• Intervention / Treatment: Device: PVC-ETT; Device: EVAC-PU-ETT

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: Interventional
• Enrollment (Actual): 1074
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PVC-ETT; Polyvinylchloride endotracheal tube	Device: PVC-ETT; Placement of a PVC-ETT in the setting of emergent intubation.; Other Names: Shiley™ Cuffed Basic Endotracheal Tube
Experimental: EVAC-PU-ETT; Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube	Device: EVAC-PU-ETT; Placement of a EVAC-PU-ETT in the setting of emergent intubation.; Other Names: Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life - 36-item Short-Form General Health Survey	Physical Component Score and Mental Component Score each have scores that range from 0 - 100; Lower scores = more disability, higher scores = less disability.	6 months
Cognitive Function	Percentage of patients cognitively impaired, assessed by the National Alzheimer Coordinating Center's Uniform Data Set	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Related Complications	The number of participants that experienced airway related adverse events.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Related Ventilator-Associated Complications (IVACs)	Center for Disease Control defined IVACs	Up to 28 days
Ventilator-Associated Events (VAEs)	Center for Disease Control defined VAEs	Up to 28 days
Healthcare costs	Healthcare resource utilization	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Oregon Health and Science University
• Investigators: Principal Investigator: Miriam M Treggiari, MD, PhD, MPH, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 3, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pneumonia; Endotracheal intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 2000027877; R33HL138650 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes