Endotracheal Tubes to Prevent Ventilator-Associated Pneumonia

NCT03705286 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: 2000027877R33HL138650
• Study Type: interventional
• Target: 1,074
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-acquired Pneumonia

Keywords

Pneumonia; Endotracheal intubation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Airway Related Complications

  6 months

Study Arms (2)

PVC-ETT

ACTIVE COMPARATOR

Polyvinylchloride endotracheal tube

Device: PVC-ETT

EVAC-PU-ETT

EXPERIMENTAL

Continuous aspiration of subglottic secretions with polyurethane cuff endotracheal tube

Device: EVAC-PU-ETT

Interventions

EVAC-PU-ETT DEVICE

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

Also known as: Shiley™ Evac Oral Tracheal Tube, SealGuard™, Murphy Eye

EVAC-PU-ETT

PVC-ETT DEVICE

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

Also known as: Shiley™ Cuffed Basic Endotracheal Tube

PVC-ETT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients electively intubated in the operating room whether or not they require subsequent ICU admission
• 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)
• Patients with permanent tracheostomy
• Protected populations including children (age \<18 years), pregnant women, or prisoners
• 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.

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Treggiari MM, Sharp ES, Ohnuma T, Fajardo EC, Aydin A, Akhtar S, Kampp M, Hashemaghaie M, Potnis A, Gugel T, Simon J, Curry LG, Adams K, Darji B, Sureshanand S, Hintz R, Lorzano SN, Johnson C, Yanez ND. Hospital and long-term outcomes for subglottic suction and polyurethane cuff versus standard endotracheal tubes in emergency intubation (PreVent 2): a randomised controlled phase 2 trial. Lancet Respir Med. 2025 Nov 27:S2213-2600(25)00294-2. doi: 10.1016/S2213-2600(25)00294-2. Online ahead of print.

  PMID: 41319662 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Miriam Treggiari
• Organization: Duke University

miriam.treggiari@duke.edu

919-681-9933

Study Officials

• Miriam M Treggiari, MD, PhD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair of Clinical Research, Anesthesiology

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 15, 2018
• Study Start: May 6, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)