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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smaller Endotracheal Tube Group | Active Comparator | For patients assigned to the smaller endotracheal tube group, the operator will place a smaller endotracheal tube, as defined below:
|
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| Larger Endotracheal Tube Group | Active Comparator | For patients assigned to the larger endotracheal tube group, the operator will place a larger endotracheal tube, as defined below:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smaller endotracheal tube | Other |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Breathlessness at 6 months after intubation | Primary Effectiveness Outcome: Breathlessness will be measured using the Clinical COPD Questionnaire (CCQ). Scores range from 0 (least severe) to 6 (most severe). | At 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free days in the first 28 days | Primary Safety Outcome: The number of days alive and free of invasive mechanical ventilation from enrollment to 28 days after enrollment. | From enrollment to 28 days after enrollment |
| All-cause, in-hospital mortality by 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful intubation on the first attempt. | Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Hospital | Birmingham | Alabama | 35233 | United States | ||
| University of Colorado-Denver |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32695994 | Background | Kempker JA, Abril MK, Chen Y, Kramer MR, Waller LA, Martin GS. The Epidemiology of Respiratory Failure in the United States 2002-2017: A Serial Cross-Sectional Study. Crit Care Explor. 2020 Jun 10;2(6):e0128. doi: 10.1097/CCE.0000000000000128. eCollection 2020 Jun. | |
| 33979490 | Background | Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available. |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel-group, pragmatic, randomized clinical trial
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| Larger endotracheal tube | Other |
|
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Primary Safety Outcome: Death from any cause from enrollment to 28 days after enrollment, censored at hospital discharge. |
| From enrollment to 28 days after enrollment |
| Voice impairment at 6 months after intubation | Secondary Effectiveness Outcome: voice impairment at 6 months after enrollment as measured using the Voice Handicap Index (VHI) survey. Scores range from 0 (least severe) to 40 (most severe). | At 6 months after enrollment |
| Swallowing impairment at 6 months after intubation | Secondary Effectiveness Outcome: Swallowing impairment at 6 months after enrollmnet as measured using the EAT-10 survey. Scores range from 0 (least severe) to 40 (most severe). | At 6 months after enrollment |
| Duration of placement of the endotracheal tube, an average duration of two minutes |
| Number of laryngoscopy attempts | Duration of placement of the endotracheal tube, an average duration of two minutes |
| Number of attempts to cannulate the trachea with a bougie | Duration of placement of the endotracheal tube, an average duration of two minutes |
| Number of attempts to cannulate the trachea with an endotracheal tube | Duration of placement of the endotracheal tube, an average duration of two minutes |
| Time from initiation of laryngoscopy to intubation of the trachea | Time from initiation of laryngoscopy to intubation of the trachea in seconds | Duration of placement of the endotracheal tube, an average of 60 seconds |
| Severe hypoxemia | Lowest oxygen saturation <80% | During procedure (between induction and 2 minutes after tracheal intubation). |
| Agitation | As measured by the occurrence of a Richmond Agitation-Sedation Scale (RASS) ≥ +2 | From intubation to 7 days after enrollment |
| Delirium | As measured by the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) | From intubation to 7 days after enrollment |
| Tracheostomy | Occurence of a tracheostomy procedure. | From intubation to 28 days after enrollment |
| Percutaneous gastrostomy tube placement | Occurence of a gastrostomy tube placement. | From intubation to 28 days after enrollment |
| Endotracheal tube exchange | Exchange of the endotracheal tube for any reason during the index course of invasive mechanical ventilation | From intubation to 28 days after enrollment |
| Reintubation within 72 hours of extubation from the index course of invasive mechanical ventilation | Any placement of an endotracheal tube in the trachea (e.g., endotracheal tube, tracheostomy) between extubation from the index course of invasive mechanical ventilation and 72 hours following extubation, excluding reintubations for the purpose of a procedure that lasts <24 hours. | Within 72 hours of extubation |
| Ventilator associated pneumonia during the index course of invasive mechanical ventilation | New lung infiltrate plus clinical evidence that the infiltrate is of an infectious origin, which include the new onset of fever, purulent sputum, leukocytosis, and decline in oxygenation, beginning > 48 hours after enrollment. | From intubation to 28 days after enrollment |
| ICU-free days in the 28 days after enrollment | From intubation to 28 days after enrollment |
| Hospital-free days in the 28 days after enrollment | From intubation to 28 days after enrollment |
| All-location mortality by 28 days | At 28 days after enrollment |
| All-cause, all-location mortality by 6 months | At 6 months after enrollment |
| Prescence of a tracheostomy at 6 months | At 6 months after enrollment |
| Cough at 6 months | As measured by the Cough Severity Index. Scores range from 0 (no cough) to 40 (severe cough). | At 6 months after enrollment |
| Throat pain at 6 months | As measured by the Numeric Rating Scale. Scores range from 0 (no pain) to 10 (most severe pain). | At 6 months after enrollment |
| Voice quality at 6 months | As measured by the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). Scores range from 0 (mildly deviant) to 100 (severely deviant). | At 6 months after enrollment |
| Quality of life at 6 months | As measured by the EQ-5D-5L health-related quality of life measure. Scores range from 0 (worst health) to 100 (best health). | At 6 months after enrollment |
| Anxiety at 6 months | As measured by the General Anxiety Disorder-7 (GAD-7). Scores range from 0 (least severe) to 21 (most severe). | At 6 months after enrollment |
| Depression at 6 months | As measured by the Patient Health Questionnaire-9. Scores range from 0 (not at all) to 27 (nearly every day). | At 6 months after enrollment |
| Employment at 6 months | As measured by the OACIS Employment Questionnaire. | At 6 months after enrollment |
| Denver |
| Colorado |
| 80045 |
| United States |
| Denver Health Medical Center | Denver | Colorado | 80204 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Washington Medical Center | Seattle | Washington | 98104 | United States |
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