Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Официальное название

A Randomized Comparison Between the Hyperangulated vs. Macintosh Blades for First-attempt Intubation Success With Videolaryngoscopy in ICU Patients.

Обзор

Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients.

Подробное описание

The purpose of this prospective multicenter randomized study is to compare successful intubation on the first attempt with the Macintosh videolaryngoscope vs the hyperangulated videolaryngoscope during tracheal intubation in ICU patients.The hypothesis of the study is that tracheal intubation using the hyperangulated videolaryngoscope will improve the frequency of successful intubation on the first attempt in ICU patients requiring intubation in the intensive care unit.

Вмешательства

• Устройство Hyperangulated blade videolaryngoscope
  For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
• Устройство Macintosh blade videolaryngoscope
  For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

Первичные конечные точки

• Difference in the first attempt intubation success rate (percentage) [Срок оценки: During intubation (minutes)]

Вторичные конечные точки (12)

• Difference in the overall success rate [Срок оценки: During intubation (minutes)]
• Number of intubation attempts [Срок оценки: During intubation (minutes)]
• Modified Cormack-Lehane grade of glottic view [Срок оценки: During intubation (minutes)]
• Diference in the incidence of "easy intubation" [Срок оценки: During intubation (minutes)]
• Duration of tracheal intubation [Срок оценки: Duration of procedure (minutes)]
• Reason for unsuccessful intubation on the first attempt [Срок оценки: Duration of procedure (minutes)]
• Number of videolaryngoscopy attempts [Срок оценки: Duration of procedure (minutes)]
• Number of attempts to cannulate the trachea with a bougie or an endotracheal tube [Срок оценки: Duration of procedure (minutes)]
• Operator-assessed difficulty of intubation [Срок оценки: Duration of procedure (minutes)]
• Need for additional airway equipment [Срок оценки: Duration of procedure (minutes)]
• Need to change the device for intubation [Срок оценки: Duration of procedure (minutes)]
• Complications of tracheal intubation [Срок оценки: Duration of procedure (minutes)]

Критерии участия

Критерии включения

• Age 18 years or older.
• Admitted to an Intensive Care Unit.
• Need for tracheal intubation during the stay in the ICU.
• The device to be used for intubation is a videolaryngoscope

Критерии исключения

• Pregnancy or lactation.
• Emergent tracheal intubation that does not allow for the randomization of the procedure.
• Need for tracheal intubation with a device other than the videolaryngoscope (fiberoptic bronchoscope, direct laryngoscopy, tracheostomy, etc.).
• Tracheal intubation performed outside the ICU (Emergency Department, Hospital ward, etc.).

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Испания · 29 центров

• University Clinical Hospital of Santiago de Compostela — Santiago de Compostela
• Complexo Hospitalario Universitario de A Coruña — A Coruña
• Hospital General de Albacete — Albacete
• Hospital de la Santa Creu i Sant Pau, Barcelona — Barcelona
• Hospital Universitario de Cáceres — Cáceres
• Hospital de Denia — Denia
• Hospital General Universitario de Eche — Elche
• Hospital Universitario de Cabueñes, Gijón — Gijón
• … и ещё 21 центр

Публикации

• Higgs A, McGrath BA, Goddard C, Rangasami J, Suntharalingam G, Gale R, Cook TM; Difficult Airway Society; Intensive Care Society; Faculty of Intensive Care Medicine; Royal College of Anaesthetists. Guidelines for the management of tracheal intubation in critically ill adults. Br J Anaesth. 2018 Feb;120(2):323-352. doi: 10.1016/j.bja.2017.10.021. Epub 2017 Nov 26. PMID 29406182
• Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz KP, Russell DW, Gaillard JP, Latimer AJ, Ghamande SA, Gibbs KW, Vonderhaar DJ, Whitson MR, Barnes CR, Walco JP, Douglas IS, Krishnamoorthy V, Dagan A, Bastman JJ, Lloyd BD, Gandotra S, Goranson JK, Mitchell SH, White HD, Palakshappa JA, Espinera A, Page DB, Joffe A, Hansen SJ, Hughes CG, George T, Herbert JT, Shapiro NI, Schauer SG, Long BJ, I PMID 37326325
• 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
• Russotto V, Lascarrou JB, Tassistro E, Parotto M, Antolini L, Bauer P, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Grasselli G, Valsecchi MG, Fumagalli R, Foti G, Caironi P, Bellani G, Laffey JG, Myatra SN; INTUBE Study Investigators. Efficacy and adverse events profile of videolaryngoscopy in critically ill patients: subanalysis of the INTUBE study. Br J Anaes PMID 37208282
• Hansel J, Rogers AM, Lewis SR, Cook TM, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adults undergoing tracheal intubation: a Cochrane systematic review and meta-analysis update. Br J Anaesth. 2022 Oct;129(4):612-623. doi: 10.1016/j.bja.2022.05.027. Epub 2022 Jul 9. PMID 35820934
• Araujo B, Rivera A, Martins S, Abreu R, Cassa P, Silva M, Gallo de Moraes A. Video versus direct laryngoscopy in critically ill patients: an updated systematic review and meta-analysis of randomized controlled trials. Crit Care. 2024 Jan 2;28(1):1. doi: 10.1186/s13054-023-04727-9. PMID 38167459
• Taboada M, Doldan P, Calvo A, Almeida X, Ferreiroa E, Baluja A, Carinena A, Otero P, Caruezo V, Naveira A, Otero P, Alvarez J. Comparison of Tracheal Intubation Conditions in Operating Room and Intensive Care Unit: A Prospective, Observational Study. Anesthesiology. 2018 Aug;129(2):321-328. doi: 10.1097/ALN.0000000000002269. PMID 29787386
• Taboada M, Estany-Gestal A, Fernandez J, Vazquez O, Pajares A, Ramasco F, Martinez S, Vallejo I, Perez A, Rama-Maceiras P, Bermudez M, Power M, Garcia-Alvarez R, Fernandez-Villa I, Aguilera JL, Carrio M, Cabadas R, Rubin A, Williams MM, Fernandez-Garcia R, Becerra A, Gine M, Garcia FJ, Iglesias MC, Santamarina RM, Del Valle S, Charco LM, Alonso MC, Rodriguez IM, Varela M, Hermoso JI, Vives M, Caba PMID 39237284

Идентификаторы

NCT: NCT06322719 · INVIBLADE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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