ENROLLING_BY_INVITATION

Tube Size Randomized Trial During Emergency Tracheal Intubation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The BREATHE trial is a parallel-group, pragmatic, randomized clinical trial comparing the effectiveness of smaller versus larger endotracheal tubes for mechanical ventilation of critically ill adults at 7 geographically diverse centers. A total of 3,180 critically ill adults undergoing tracheal intubation in the ED or ICU will be enrolled. Enrolled patients will be randomly assigned in a 1:1 ratio to receive either a smaller endotracheal tube (a 6.5 mm endotracheal tube for patients shorter than 64 inches and a 7.0 mm endotracheal for patients at least 64 inches) or a larger endotracheal tube (a 7.5 mm endotracheal tube for patients shorter than 64 inches and a 8.0 mm endotracheal for patients at least 64 inches). Patients will be followed for 6 months after enrollment. The primary outcome will be breathlessness at 6 months. The secondary outcomes will be voice quality and swallowing at 6 months.

Official Title

The Tube Size Randomized Trial During Emergency Tracheal Intubation

Quick Facts

Study Start:2025-05-06
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06939361

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is undergoing orotracheal intubation with an endotracheal tube in a participating unit
  2. * Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
  1. * Patient is known to be less than 18 years old
  2. * Patient is known to be pregnant
  3. * Patient is known to be a prisoner
  4. * Use of an endotracheal tube with subglottic suction is planned
  5. * Operator has determined that use of a smaller endotracheal tube or a larger endotracheal tube is required or contraindicated for the optimal care of the patient
  6. * Immediate need for tracheal intubation precludes safe performance of study procedures

Contacts and Locations

Study Locations (Sites)

University of Alabama Hospital
Birmingham, Alabama, 35233
United States
University of Colorado-Denver
Denver, Colorado, 80045
United States
Denver Health Medical Center
Denver, Colorado, 80204
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
University of Washington Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2029-06

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • critical illness
  • emergency airway management
  • tracheal intubation

Additional Relevant MeSH Terms

  • Acute Respiratory Failure