Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia

NCT ID: NCT03705286

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1074 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-06
• Study Completion Date: 2023-02-23

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.

Conditions

Ventilator-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PVC-ETT

Polyvinylchloride endotracheal tube

Group Type: ACTIVE_COMPARATOR

PVC-ETT

Intervention Type: DEVICE

Placement of a PVC-ETT in the setting of emergent intubation.

EVAC-PU-ETT

Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube

Group Type: EXPERIMENTAL

EVAC-PU-ETT

Intervention Type: DEVICE

Placement of a EVAC-PU-ETT in the setting of emergent intubation.

Interventions

EVAC-PU-ETT

Placement of a EVAC-PU-ETT in the setting of emergent intubation.

Intervention Type: DEVICE

PVC-ETT

Placement of a PVC-ETT in the setting of emergent intubation.

Intervention Type: DEVICE

Other Intervention Names

Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy Eye; Shiley™ Cuffed Basic Endotracheal Tube

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Miriam Treggiari

Professor, Vice Chair of Clinical Research, Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam M Treggiari, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R33HL138650

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000027877

Identifier Type: -

Identifier Source: org_study_id