Tube Size Randomized Trial During Emergency Tracheal Intubation

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06939361
Status
Enrolling By Invitation

Conditions

  • Acute Respiratory Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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)
  • 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)

Study Details

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.

Key Dates

Start date
May 6, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
3,180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Smaller Endotracheal Tube Group
    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)
  • Active Comparator: Larger Endotracheal Tube Group
    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)

Primary Outcome Measure

Breathlessness at 6 months after intubation [ Time Frame: At 6 months after enrollment ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama HospitalBirminghamAlabama35233-
Denver Health Medical CenterDenverColorado80204-
University of Colorado-DenverDenverColorado80045-
Hennepin County Medical CenterMinneapolisMinnesota55415-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Washington Medical CenterSeattleWashington98104-

Find similar trials in Birmingham, AL

By research site
University of Alabama Hospital· Birmingham, ALDenver Health Medical Center· Denver, COUniversity of Colorado-Denver· Denver, COHennepin County Medical Center· Minneapolis, MNAtrium Health Wake Forest Baptist· Winston-Salem, NCVanderbilt University Medical Center· Nashville, TN

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