Endotracheal Tube Size for Acute Respiratory Failure

(BREATHE Trial)

Recruiting at 6 trial locations

Overseen By Alexander H. Gelbard, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Under 18, Pregnant, Prisoner, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate

3180 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use different sizes of endotracheal tubes in humans?

Using larger endotracheal tubes can increase the risk of throat and voice box injuries, which might affect recovery and quality of life. Inappropriately sized tubes can also cause long-term injuries that may need surgery. ^{1 2 3 4 5}

How does the endotracheal tube size treatment for acute respiratory failure differ from other treatments?

This treatment is unique because it involves selecting different sizes of endotracheal tubes (tubes inserted into the windpipe to help with breathing) to manage acute respiratory failure. The choice between larger and smaller tubes can impact the patient's recovery and risk of complications, such as laryngeal injury or breathing difficulties, which is not a consideration in many other treatments for respiratory failure. ^{3 4 6 7 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for critically ill adults who need a breathing tube due to emergency and severe respiratory failure. Participants will be chosen from different centers and must be undergoing tracheal intubation in the ED or ICU.

Inclusion Criteria

I am having a procedure with a breathing tube in a participating unit.

My procedure will be done by a clinician skilled in tracheal intubation.

Exclusion Criteria

I am under 18 years old.

Patient is known to be pregnant

Patient is known to be a prisoner

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo tracheal intubation with either a smaller or larger endotracheal tube

Immediate

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety outcomes such as ventilator-free days and in-hospital mortality

28 days

Long-term Follow-up

Participants are assessed for long-term outcomes including breathlessness, voice quality, and swallowing impairment

6 months

Treatment Details

Interventions

• Larger endotracheal tube
• Smaller endotracheal tube

Trial Overview The BREATHE trial tests whether smaller or larger endotracheal tubes are more effective for mechanical ventilation. Patients are randomly assigned to receive either size, based on their height, and monitored for breathlessness, voice quality, and swallowing over 6 months.

Participant Groups

Group I: Smaller Endotracheal Tube Group Active Control 1 Intervention

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 II: Larger Endotracheal Tube Group Active Control 1 Intervention

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)

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Current Practices in Endotracheal Tube Size Selection for Adults. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Endotracheal Tube Size Is Associated With Mortality in Patients With Status Asthmaticus. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Endotracheal Tube Size in Critically Ill Patients. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Frequency of the requirement of inappropriate uncuffed tracheal tube size for pediatric patients: a retrospective observational analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Small endotracheal tubes: ventilator and intratracheal pressures during controlled ventilation. [2019]

7. Nigeria pubmed.ncbi.nlm.nih.gov

Tracheal-tube size requirement of adult Nigerians. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Tracheal tube size in adults undergoing elective surgery - a narrative review. [2020]