Tube Size Randomized Trial During Emergency Tracheal Intubation

Официальное название

The Tube Size Randomized Trial During Emergency Tracheal Intubation

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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)
• Другое 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)

Первичные конечные точки

• Breathlessness at 6 months after intubation [Срок оценки: At 6 months after enrollment]

Вторичные конечные точки (4)

• Ventilator-free days in the first 28 days [Срок оценки: From enrollment to 28 days after enrollment]
• All-cause, in-hospital mortality by 28 days [Срок оценки: From enrollment to 28 days after enrollment]
• Voice impairment at 6 months after intubation [Срок оценки: At 6 months after enrollment]
• Swallowing impairment at 6 months after intubation [Срок оценки: At 6 months after enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• University of Alabama Hospital — Birmingham
• University of Colorado-Denver — Denver
• Denver Health Medical Center — Denver
• Hennepin County Medical Center — Minneapolis
• Atrium Health Wake Forest Baptist — Winston-Salem
• Vanderbilt University Medical Center — Nashville
• University of Washington Medical Center — Seattle

Публикации

• 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. PMID 32695994
• 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. PMID 33979490
• Russotto 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. PMID 33755076
• Driver 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. PMID 26850232
• Demoule 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. 20 PMID 35061577
• Nanwani-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: 10.1 PMID 35562379
• Dowdy 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. PMID 16783553
• Heyland 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. PMID 16003061

Идентификаторы

NCT: NCT06939361 · 250125

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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