Acute Respiratory FailureBREATHENCT06939361
Tube Size Randomized Trial During Emergency Tracheal Intubation
A study testing Smaller endotracheal tube and Larger endotracheal tube in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Smaller endotracheal tube and Larger endotracheal tube
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,180 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 May 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
University of Alabama Hospital
Birmingham, Alabama, 35233
University of Colorado-Denver
Denver, Colorado, 80045
Denver Health Medical Center
Denver, Colorado, 80204
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Washington Medical Center
Seattle, Washington, 98104
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: The Tube Size Randomized Trial During Emergency Tracheal Intubation
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.
Read the 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Smaller endotracheal tube, Larger endotracheal tube
- Keywords
- critical illness, emergency airway management, tracheal intubation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smaller endotracheal tubeOther
- 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 tubeOther
- Inner diameter 8.0 mm (for patients with a height ≥ 64 inches)
- Inner diameter 7.5 mm (for patients with a height < 64 inches)
| Study group | Role | What they receive |
|---|---|---|
| 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:
* Inner diameter 7.0 mm (for patients with a height ≥ 64 inches)
* Inner diameter 6.5 mm (for patients with a height < 64 inches) Receives: Other: Smaller endotracheal tube |
| 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:
* Inner diameter 8.0 mm (for patients with a height ≥ 64 inches)
* Inner diameter 7.5 mm (for patients with a height < 64 inches) Receives: Other: Larger endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 6 months after enrollment
Secondary outcomes (4)
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.
Measured: From enrollment to 28 days after enrollment
All-cause, in-hospital mortality by 28 days
Primary Safety Outcome: Death from any cause from enrollment to 28 days after enrollment, censored at hospital discharge.
Measured: 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-10 (VHI-10) survey. Scores range from 0 (least severe) to 40 (most severe).
Measured: At 6 months after enrollment
Swallowing impairment at 6 months after intubation
Secondary Effectiveness Outcome: Swallowing impairment at 6 months after enrollment as measured using the EAT-10 survey. Scores range from 0 (least severe) to 40 (most severe).
Measured: At 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start6 May 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, pragmatic, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 3,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Jonathan Casey, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939361
- Sponsor's protocol ID
- 250125
- Acronym
- BREATHE
- Status last verified
- Sep 2026
- First submitted
- 7 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32695994Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
PubMed 33979490Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.
PubMed 33755076Driver BE, Prekker ME, Moore JC, Schick AL, Reardon RF, Miner JR. Direct Versus Video Laryngoscopy Using the C-MAC for Tracheal Intubation in the Emergency Department, a Randomized Controlled Trial. Acad Emerg Med. 2016 Apr;23(4):433-9. doi: 10.1111/acem.12933. Epub 2016 Mar 24.
PubMed 26850232Demoule A, Hajage D, Messika J, Jaber S, Diallo H, Coutrot M, Kouatchet A, Azoulay E, Fartoukh M, Hraiech S, Beuret P, Darmon M, Decavele M, Ricard JD, Chanques G, Mercat A, Schmidt M, Similowski T; REVA Network (Research Network in Mechanical Ventilation). Prevalence, Intensity, and Clinical Impact of Dyspnea in Critically Ill Patients Receiving Invasive Ventilation. Am J Respir Crit Care Med. 2022 Apr 15;205(8):917-926. doi: 10.1164/rccm.202108-1857OC.
PubMed 35061577Nanwani-Nanwani K, Lopez-Perez L, Gimenez-Esparza C, Ruiz-Barranco I, Carrillo E, Arellano MS, Diaz-Diaz D, Hurtado B, Garcia-Munoz A, Relucio MA, Quintana-Diaz M, Urbez MR, Saravia A, Bonan MV, Garcia-Rio F, Testillano ML, Villar J, Garcia de Lorenzo A, Anon JM. Prevalence of post-intensive care syndrome in mechanically ventilated patients with COVID-19. Sci Rep. 2022 May 13;12(1):7977. doi: 10.1038/s41598-022-11929-8.
PubMed 35562379Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.
PubMed 16783553Heyland DK, Groll D, Caeser M. Survivors of acute respiratory distress syndrome: relationship between pulmonary dysfunction and long-term health-related quality of life. Crit Care Med. 2005 Jul;33(7):1549-56. doi: 10.1097/01.ccm.0000168609.98847.50.
PubMed 16003061Hudson LD. What happens to survivors of the adult respiratory distress syndrome? Chest. 1994 Mar;105(3 Suppl):123S-126S. doi: 10.1378/chest.105.3_supplement.123s. No abstract available.
PubMed 8131606Davidson TA, Caldwell ES, Curtis JR, Hudson LD, Steinberg KP. Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients. JAMA. 1999 Jan 27;281(4):354-60. doi: 10.1001/jama.281.4.354.
PubMed 9929089Miles A, McRae J, Clunie G, Gillivan-Murphy P, Inamoto Y, Kalf H, Pillay M, Pownall S, Ratcliffe P, Richard T, Robinson U, Wallace S, Brodsky MB. An International Commentary on Dysphagia and Dysphonia During the COVID-19 Pandemic. Dysphagia. 2022 Dec;37(6):1349-1374. doi: 10.1007/s00455-021-10396-z. Epub 2022 Jan 4.
PubMed 34981255Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
PubMed 20202948Brodsky 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.
PubMed 25387319Karmali 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.
PubMed 32415788Karmakar A, Pate MB, Solowski NL, Postma GN, Weinberger PM. Tracheal size variability is associated with sex: implications for endotracheal tube selection. Ann Otol Rhinol Laryngol. 2015 Feb;124(2):132-6. doi: 10.1177/0003489414549154. Epub 2014 Oct 10.
PubMed 25305266
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tube Size Randomized Trial During Emergency Tracheal Intubation
- ClinicalTrials.gov ID
- NCT06939361
- Acronym / sponsor ID
- BREATHE / 250125
- Conditions
- Acute Respiratory Failure
- Keywords
- critical illness, emergency airway management, tracheal intubation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,180 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 6 May 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, pragmatic, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Smaller Endotracheal Tube Group | Active comparator | Other: Smaller endotracheal tubeFor 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) |
| Larger Endotracheal Tube Group | Active comparator | Other: Larger endotracheal tubeFor 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Other | Smaller Endotracheal Tube Group |
| 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) | Other | Larger Endotracheal Tube Group |
Primary outcome
Breathlessness at 6 months after intubation
Time frame: At 6 months after enrollment
Primary Effectiveness Outcome: Breathlessness will be measured using the Clinical COPD Questionnaire (CCQ). Scores range from 0 (least severe) to 6 (most severe).
4 secondary outcomes
Ventilator-free days in the first 28 days
Time frame: From enrollment to 28 days after enrollment
All-cause, in-hospital mortality by 28 days
Time frame: From enrollment to 28 days after enrollment
Voice impairment at 6 months after intubation
Time frame: At 6 months after enrollment
Swallowing impairment at 6 months after intubation
Time frame: At 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 32695994Kempker 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.
- Background: PubMed 33979490Heidegger T. Management of the Difficult Airway. N Engl J Med. 2021 May 13;384(19):1836-1847. doi: 10.1056/NEJMra1916801. No abstract available.
- Background: PubMed 33755076Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.
- Background: PubMed 26850232Driver BE, Prekker ME, Moore JC, Schick AL, Reardon RF, Miner JR. Direct Versus Video Laryngoscopy Using the C-MAC for Tracheal Intubation in the Emergency Department, a Randomized Controlled Trial. Acad Emerg Med. 2016 Apr;23(4):433-9. doi: 10.1111/acem.12933. Epub 2016 Mar 24.
- Background: PubMed 35061577Demoule A, Hajage D, Messika J, Jaber S, Diallo H, Coutrot M, Kouatchet A, Azoulay E, Fartoukh M, Hraiech S, Beuret P, Darmon M, Decavele M, Ricard JD, Chanques G, Mercat A, Schmidt M, Similowski T; REVA Network (Research Network in Mechanical Ventilation). Prevalence, Intensity, and Clinical Impact of Dyspnea in Critically Ill Patients Receiving Invasive Ventilation. Am J Respir Crit Care Med. 2022 Apr 15;205(8):917-926. doi: 10.1164/rccm.202108-1857OC.
- Background: PubMed 35562379Nanwani-Nanwani K, Lopez-Perez L, Gimenez-Esparza C, Ruiz-Barranco I, Carrillo E, Arellano MS, Diaz-Diaz D, Hurtado B, Garcia-Munoz A, Relucio MA, Quintana-Diaz M, Urbez MR, Saravia A, Bonan MV, Garcia-Rio F, Testillano ML, Villar J, Garcia de Lorenzo A, Anon JM. Prevalence of post-intensive care syndrome in mechanically ventilated patients with COVID-19. Sci Rep. 2022 May 13;12(1):7977. doi: 10.1038/s41598-022-11929-8.
- Background: PubMed 16783553Dowdy DW, Eid MP, Dennison CR, Mendez-Tellez PA, Herridge MS, Guallar E, Pronovost PJ, Needham DM. Quality of life after acute respiratory distress syndrome: a meta-analysis. Intensive Care Med. 2006 Aug;32(8):1115-24. doi: 10.1007/s00134-006-0217-3. Epub 2006 Jun 17.
- Background: PubMed 16003061Heyland DK, Groll D, Caeser M. Survivors of acute respiratory distress syndrome: relationship between pulmonary dysfunction and long-term health-related quality of life. Crit Care Med. 2005 Jul;33(7):1549-56. doi: 10.1097/01.ccm.0000168609.98847.50.
- Background: PubMed 8131606Hudson LD. What happens to survivors of the adult respiratory distress syndrome? Chest. 1994 Mar;105(3 Suppl):123S-126S. doi: 10.1378/chest.105.3_supplement.123s. No abstract available.
- Background: PubMed 9929089Davidson TA, Caldwell ES, Curtis JR, Hudson LD, Steinberg KP. Reduced quality of life in survivors of acute respiratory distress syndrome compared with critically ill control patients. JAMA. 1999 Jan 27;281(4):354-60. doi: 10.1001/jama.281.4.354.
- Background: PubMed 34981255Miles A, McRae J, Clunie G, Gillivan-Murphy P, Inamoto Y, Kalf H, Pillay M, Pownall S, Ratcliffe P, Richard T, Robinson U, Wallace S, Brodsky MB. An International Commentary on Dysphagia and Dysphonia During the COVID-19 Pandemic. Dysphagia. 2022 Dec;37(6):1349-1374. doi: 10.1007/s00455-021-10396-z. Epub 2022 Jan 4.
- Background: PubMed 20202948Skoretz SA, Flowers HL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010 Mar;137(3):665-73. doi: 10.1378/chest.09-1823.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smaller endotracheal tube and Larger endotracheal tube in people with Acute Respiratory Failure, run by Vanderbilt University Medical Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness at 6 months after intubation (time frame: At 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06939361, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.