Endotracheal Tube Size for Acute Respiratory Failure

(BREATHE Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which size of endotracheal tube (a tube inserted into the windpipe) is more effective for adults needing breathing assistance due to critical illness. Researchers compare smaller tubes to larger ones to determine which better reduces breathlessness after six months. The trial also assesses voice quality and swallowing. It suits critically ill patients about to be intubated in an emergency or intensive care unit. As an unphased trial, it allows patients to contribute to important research that could enhance intubation practices and outcomes.

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.

What prior data suggests that these endotracheal tube sizes are safe for critically ill adults?

Research has shown that smaller breathing tubes are generally well-tolerated by patients with severe illness and breathing problems. Studies suggest these tubes have manageable side effects and can work effectively without significantly increasing risks.

In contrast, larger breathing tubes may raise the risk of throat and voice box issues. They also pose a chance of direct airway injury and procedural complications if the tube is too large.

Both sizes of tubes have been used in medical settings, but larger ones carry slightly more risk. These findings can help patients consider potential side effects when deciding whether to join trials like the BREATHE trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the size of endotracheal tubes can impact the management of acute respiratory failure. Most current treatments focus on ventilation support without considering tube size as a variable. This trial is unique because it compares smaller and larger endotracheal tubes to see if one size offers better outcomes in terms of comfort and effectiveness. By examining tube size, researchers hope to optimize airway management and improve patient care during critical respiratory conditions.

What evidence suggests that this trial's treatments could be effective for acute respiratory failure?

This trial will compare smaller and larger endotracheal tubes in patients with acute respiratory failure. Research has shown that the size of the breathing tube can affect recovery. Participants in the smaller endotracheal tube group will receive tubes with an inner diameter of 7.0 mm or 6.5 mm, depending on their height. Those in the larger endotracheal tube group will receive tubes with an inner diameter of 8.0 mm or 7.5 mm. Studies suggest that the choice between smaller and larger tubes can influence recovery aspects like difficulty breathing and swallowing. Evidence indicates a balance might exist between tube effectiveness and the risk of aspirating food or liquid into the lungs with different tube sizes. Although more research is needed, both tube sizes have shown potential in aiding patients who require breathing assistance. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9993497/

Endotracheal Tube Size Is Associated With Mortality in ... Severe asthma escalating to status asthmaticus can rapidly progress to respiratory failure, ICU admission, and endotracheal intubation. ... Incidence and outcomes ...

2. withpower.com withpower.com/trial/phase-emergencies-3-2025-8451e

Endotracheal Tube Size for Acute Respiratory Failure · Info ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7644217/

The association between endotracheal tube size and ... The association between endotracheal tube size and aspiration (during FEES) in acute respiratory failure survivors ... outcomes in acute respiratory distress ...

4. emergencymed.org.il emergencymed.org.il/wp-content/uploads/2021/07/134_2021_Article_6417.pdf

Effect of the use of an endotracheal tube and stylet versus an ... Acute respiratory failure is among the leading causes of intensive care unit (ICU) admission and tracheal intuba- tion for invasive mechanical ventilation in ...

5. liebertpub.com liebertpub.com/doi/10.4187/respcare.09348

Clinical Outcomes of Acute Respiratory Failure Associated ... The objectives of this study were to compare relevant PICU clinical outcomes of children with acute respiratory failure who were successfully treated with NIV, ...

6. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2794663

Endotracheal Tube Size in Critically Ill Patients ... tubes are noninferior to larger endotracheal tubes with respect to critical illness outcomes ... The epidemiology of respiratory failure in the ...

7. publications.aap.org publications.aap.org/pediatrics/article/153/4/e2023062925/196867/Endotracheal-Tube-Size-Adjustments-Within-Seven

Endotracheal Tube Size Adjustments Within Seven Days of ... ETTs that are sized too large increase the risk for direct airway injury, intubation procedural failure, and potential for long-term damage ...