Clinical trial NCT06939361: Tube Size Randomized Trial During Emergency Tracheal Intubation
Official title: The Tube Size Randomized Trial During Emergency Tracheal Intubation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: critical illness
emergency airway management
tracheal intubation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-04-22
Enrollment: 3180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group, pragmatic, randomized clinical trial
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Breathlessness at 6 months after intubation
timeFrame: At 6 months after enrollment
Secondary outcomes:
measure: Ventilator-free days in the first 28 days
timeFrame: From enrollment to 28 days after enrollment
measure: All-cause, in-hospital mortality by 28 days
timeFrame: From enrollment to 28 days after enrollment
measure: Voice impairment at 6 months after intubation
timeFrame: At 6 months after enrollment
measure: Swallowing impairment at 6 months after intubation
timeFrame: At 6 months after enrollment
Other outcomes:
measure: Successful intubation on the first attempt.
timeFrame: Duration of placement of the endotracheal tube, an average duration of two minutes
measure: Number of laryngoscopy attempts
timeFrame: Duration of placement of the endotracheal tube, an average duration of two minutes
measure: Number of attempts to cannulate the trachea with a bougie
timeFrame: Duration of placement of the endotracheal tube, an average duration of two minutes
measure: Number of attempts to cannulate the trachea with an endotracheal tube
timeFrame: Duration of placement of the endotracheal tube, an average duration of two minutes
measure: Time from initiation of laryngoscopy to intubation of the trachea
timeFrame: Duration of placement of the endotracheal tube, an average of 60 seconds
measure: Severe hypoxemia
timeFrame: During procedure (between induction and 2 minutes after tracheal intubation).
measure: Agitation
timeFrame: From intubation to 7 days after enrollment
measure: Delirium
timeFrame: From intubation to 7 days after enrollment
measure: Tracheostomy
timeFrame: From intubation to 28 days after enrollment
measure: Percutaneous gastrostomy tube placement
timeFrame: From intubation to 28 days after enrollment
measure: Endotracheal tube exchange
timeFrame: From intubation to 28 days after enrollment
measure: Reintubation within 72 hours of extubation from the index course of invasive mechanical ventilation
timeFrame: Within 72 hours of extubation
measure: Ventilator associated pneumonia during the index course of invasive mechanical ventilation
timeFrame: From intubation to 28 days after enrollment
measure: ICU-free days in the 28 days after enrollment
timeFrame: From intubation to 28 days after enrollment
measure: Hospital-free days in the 28 days after enrollment
timeFrame: From intubation to 28 days after enrollment
measure: All-location mortality by 28 days
timeFrame: At 28 days after enrollment
measure: All-cause, all-location mortality by 6 months
timeFrame: At 6 months after enrollment
measure: Prescence of a tracheostomy at 6 months
timeFrame: At 6 months after enrollment
measure: Cough at 6 months
timeFrame: At 6 months after enrollment
measure: Throat pain at 6 months
timeFrame: At 6 months after enrollment
measure: Voice quality at 6 months
timeFrame: At 6 months after enrollment
measure: Quality of life at 6 months
timeFrame: At 6 months after enrollment
measure: Anxiety at 6 months
timeFrame: At 6 months after enrollment
measure: Depression at 6 months
timeFrame: At 6 months after enrollment
measure: Employment at 6 months
timeFrame: At 6 months after enrollment
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Denver
country: United States
facility: University of Colorado-Denver
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
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