Tube Size Randomized Trial During Emergency Tracheal Intubation

NCT06939361 | Enrolling By Invitation DMC

• 1 other identifier: 250125
• Study Type: interventional
• Target: 3,180
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Acute Respiratory Failure

Keywords

critical illness; emergency airway management; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Breathlessness at 6 months after intubation

  Primary Effectiveness Outcome: Breathlessness will be measured using the Clinical COPD Questionnaire (CCQ). Scores range from 0 (least severe) to 6 (most severe).

  At 6 months after enrollment

Secondary Outcomes (4)

• Ventilator-free days in the first 28 days

  From enrollment to 28 days after enrollment

• All-cause, in-hospital mortality by 28 days

  From enrollment to 28 days after enrollment

• Voice impairment at 6 months after intubation

  At 6 months after enrollment

• Swallowing impairment at 6 months after intubation

  At 6 months after enrollment

Other Outcomes (25)

• Successful intubation on the first attempt.

  Duration of placement of the endotracheal tube, an average duration of two minutes

• Number of laryngoscopy attempts

  Duration of placement of the endotracheal tube, an average duration of two minutes

• Number of attempts to cannulate the trachea with a bougie

  Duration of placement of the endotracheal tube, an average duration of two minutes

Study Arms (2)

Smaller Endotracheal Tube Group

ACTIVE COMPARATOR

For patients assigned to the smaller endotracheal tube group, the operator will place a smaller endotracheal tube, as defined below: * Inner diameter 7.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 6.5 mm (for patients with a height \< 64 inches)

Other: Smaller endotracheal tube

Larger Endotracheal Tube Group

ACTIVE COMPARATOR

For patients assigned to the larger endotracheal tube group, the operator will place a larger endotracheal tube, as defined below: * Inner diameter 8.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 7.5 mm (for patients with a height \< 64 inches)

Other: Larger endotracheal tube

Interventions

Smaller endotracheal tube OTHER

* Inner diameter 7.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 6.5 mm (for patients with a height \< 64 inches)

Smaller Endotracheal Tube Group

Larger endotracheal tube OTHER

* Inner diameter 8.0 mm (for patients with a height ≥ 64 inches) * Inner diameter 7.5 mm (for patients with a height \< 64 inches)

Larger Endotracheal Tube Group

Eligibility Criteria

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

You may qualify if:

• Patient is undergoing orotracheal intubation with an endotracheal tube in a participating unit
• Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit

You may not qualify if:

• Patient is known to be less than 18 years old
• Patient is known to be pregnant
• Patient is known to be a prisoner
• Use of an endotracheal tube with subglottic suction is planned
• 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
• Immediate need for tracheal intubation precludes safe performance of study procedures

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (7)

University of Alabama Hospital

Birmingham, Alabama, 35233, United States

Location

University of Colorado-Denver

Denver, Colorado, 80045, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Washington Medical Center

Seattle, Washington, 98104, United States

Location

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MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Parallel-group, pragmatic, randomized clinical trial

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (7)