Tube Size Randomized Trial During Emergency Tracheal Intubation
NCT ID: NCT06939361
Last Updated: 2025-12-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ENROLLING_BY_INVITATION
Clinical Phase
NA
Total Enrollment
3180 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-06
Study Completion Date
2029-06-30
Brief Summary
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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.
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Detailed Description
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Each year, approximately 1% of the US population (2-3 million adults) experiences critical illness requiring placement of an endotracheal tube. While 60-80% of patients survive, more than half of survivors experience long-term problems with breathing, speaking, or swallowing. Identifying approaches that prevent long-term complications of critical illness is an urgent priority.
For every patient undergoing emergency tracheal intubation, clinicians select the size of endotracheal tube. The size of the endotracheal tube refers to the inner diameter of the tube. Smaller endotracheal tubes commonly used in adults have a diameter of 6.5 mm to 7.0 mm. Larger endotracheal tubes commonly used in adults have a diameter of 7.5 mm to 8.0 mm.
In current clinical care, some clinicians routinely use smaller endotracheal tubes while others routinely use larger endotracheal tubes. In a cohort of 2,652 patients enrolled in three recent trials conducted by our Pragmatic Critical Care Research Group (PCCRG), clinicians used a smaller endotracheal tube for 44.5% of patients and a larger endotracheal tube for 55.5%. While height and sex are the primary determinants of the diameter of a patient's trachea, these variables explain only 12% of the variation in the size of endotracheal tube clinicians use in current clinical care. This suggests that selection of endotracheal tube size in clinical practice is not "personalized" to the characteristics of the patient, but instead varies based on factors like the specialty of the clinician, the practice patterns of the hospital, and the region of the country.
Whether using a smaller vs larger endotracheal tube affects any patient outcome is unknown. Some experts have hypothesized that use of larger endotracheal tubes may cause acute injury to the larynx, which for some patients could progress to permanent scarring, impairing breathing, speaking, and swallowing. Thus, some experts currently recommend using smaller endotracheal tubes. Other experts hypothesize that the use of larger endotracheal tubes may reduce resistance to gas flow, reducing patients' work of breathing during spontaneous breathing trials, and making it easier to pass suction catheters, obtain diagnostic samples, and clear secretions. Such experts, therefore, currently recommend using larger endotracheal tubes in hopes that doing so might shorten the duration of invasive mechanical ventilation or even decrease the risk of death during critical illness. No randomized trials have ever compared smaller versus larger endotracheal tube sizes among critically ill adults. Only one observational study has evaluated the effect of endotracheal tube size on outcomes of critical illness. It suggested that smaller endotracheal tubes had no effect on survival to hospital discharge but could not exclude the possibility that endotracheal tube size might affect the duration of invasive mechanical ventilation. The study prompted published responses highlighting the lack of long-term outcomes and the biases inherent to observational studies, noting that the effects of smaller versus larger endotracheal tubes could only be proven with a randomized trial.
Because millions of critically ill adults receive either a smaller or larger endotracheal tube during tracheal intubation in an ED or ICU each year, and no prior randomized trial has evaluated the effect of endotracheal tube size on long-term outcomes (breathing, speaking, and swallowing) or short-term outcomes (duration of invasive mechanical ventilation and survival), a multicenter randomized trial is needed.
For every patient undergoing emergency tracheal intubation, clinicians select the size of endotracheal tube. The size of the endotracheal tube refers to the inner diameter of the tube. Smaller endotracheal tubes commonly used in adults have a diameter of 6.5 mm to 7.0 mm. Larger endotracheal tubes commonly used in adults have a diameter of 7.5 mm to 8.0 mm.
In current clinical care, some clinicians routinely use smaller endotracheal tubes while others routinely use larger endotracheal tubes. In a cohort of 2,652 patients enrolled in three recent trials conducted by our Pragmatic Critical Care Research Group (PCCRG), clinicians used a smaller endotracheal tube for 44.5% of patients and a larger endotracheal tube for 55.5%. While height and sex are the primary determinants of the diameter of a patient's trachea, these variables explain only 12% of the variation in the size of endotracheal tube clinicians use in current clinical care. This suggests that selection of endotracheal tube size in clinical practice is not "personalized" to the characteristics of the patient, but instead varies based on factors like the specialty of the clinician, the practice patterns of the hospital, and the region of the country.
Whether using a smaller vs larger endotracheal tube affects any patient outcome is unknown. Some experts have hypothesized that use of larger endotracheal tubes may cause acute injury to the larynx, which for some patients could progress to permanent scarring, impairing breathing, speaking, and swallowing. Thus, some experts currently recommend using smaller endotracheal tubes. Other experts hypothesize that the use of larger endotracheal tubes may reduce resistance to gas flow, reducing patients' work of breathing during spontaneous breathing trials, and making it easier to pass suction catheters, obtain diagnostic samples, and clear secretions. Such experts, therefore, currently recommend using larger endotracheal tubes in hopes that doing so might shorten the duration of invasive mechanical ventilation or even decrease the risk of death during critical illness. No randomized trials have ever compared smaller versus larger endotracheal tube sizes among critically ill adults. Only one observational study has evaluated the effect of endotracheal tube size on outcomes of critical illness. It suggested that smaller endotracheal tubes had no effect on survival to hospital discharge but could not exclude the possibility that endotracheal tube size might affect the duration of invasive mechanical ventilation. The study prompted published responses highlighting the lack of long-term outcomes and the biases inherent to observational studies, noting that the effects of smaller versus larger endotracheal tubes could only be proven with a randomized trial.
Because millions of critically ill adults receive either a smaller or larger endotracheal tube during tracheal intubation in an ED or ICU each year, and no prior randomized trial has evaluated the effect of endotracheal tube size on long-term outcomes (breathing, speaking, and swallowing) or short-term outcomes (duration of invasive mechanical ventilation and survival), a multicenter randomized trial is needed.
Conditions
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Acute Respiratory Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Parallel-group, pragmatic, randomized clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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)
Group Type
ACTIVE_COMPARATOR
Smaller endotracheal tube
Intervention Type
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 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)
Group Type
ACTIVE_COMPARATOR
Larger endotracheal tube
Intervention Type
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)
Interventions
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Smaller endotracheal tube
* Inner diameter 7.0 mm (for patients with a height ≥ 64 inches)
* Inner diameter 6.5 mm (for patients with a height \< 64 inches)
Intervention Type
OTHER
Larger endotracheal tube
* Inner diameter 8.0 mm (for patients with a height ≥ 64 inches)
* Inner diameter 7.5 mm (for patients with a height \< 64 inches)
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Sponsor Role
collaborator
Vanderbilt University Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Jonathan Casey
Primary Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
Site Status
University of Colorado-Denver
Denver, Colorado, United States
Site Status
Denver Health Medical Center
Denver, Colorado, United States
Site Status
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Site Status
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Site Status
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Site Status
University of Washington Medical Center
Seattle, Washington, United States
Site Status
Countries
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United States
References
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Brodsky MB, Gonzalez-Fernandez M, Mendez-Tellez PA, Shanholtz C, Palmer JB, Needham DM. Factors associated with swallowing assessment after oral endotracheal intubation and mechanical ventilation for acute lung injury. Ann Am Thorac Soc. 2014 Dec;11(10):1545-52. doi: 10.1513/AnnalsATS.201406-274OC.
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Karmali S, Rose P. Tracheal tube size in adults undergoing elective surgery - a narrative review. Anaesthesia. 2020 Nov;75(11):1529-1539. doi: 10.1111/anae.15041. Epub 2020 May 16.
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BACKGROUND
Farrow S, Farrow C, Soni N. Size matters: choosing the right tracheal tube. Anaesthesia. 2012 Aug;67(8):815-9. doi: 10.1111/j.1365-2044.2012.07250.x. No abstract available.
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Brenner MJ, Brodsky MB, Rassekh CH. Reassessing Endotracheal Tube Size in Critically Ill Patients. JAMA Otolaryngol Head Neck Surg. 2023 Feb 1;149(2):188. doi: 10.1001/jamaoto.2022.4273. No abstract available.
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Reference Type
BACKGROUND
Other Identifiers
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250125
Identifier Type: -
Identifier Source: org_study_id
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