Clinical trial NCT06322719: Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU
Official title: A Randomized Comparison Between the Hyperangulated vs. Macintosh Blades for First-attempt Intubation Success With Videolaryngoscopy in ICU Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Intubation
Intubation; Difficult or Failed
Videolaryngoscopy
Intubation Complication
Keywords: videolaryngoscopy
tracheal intubation
complication
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Difference in the first attempt intubation success rate (percentage)
timeFrame: During intubation (minutes)
Secondary outcomes:
measure: Difference in the overall success rate
timeFrame: During intubation (minutes)
measure: Number of intubation attempts
timeFrame: During intubation (minutes)
measure: Modified Cormack-Lehane grade of glottic view
timeFrame: During intubation (minutes)
measure: Diference in the incidence of "easy intubation"
timeFrame: During intubation (minutes)
measure: Duration of tracheal intubation
timeFrame: Duration of procedure (minutes)
measure: Reason for unsuccessful intubation on the first attempt
timeFrame: Duration of procedure (minutes)
measure: Number of videolaryngoscopy attempts
timeFrame: Duration of procedure (minutes)
measure: Number of attempts to cannulate the trachea with a bougie or an endotracheal tube
timeFrame: Duration of procedure (minutes)
measure: Operator-assessed difficulty of intubation
timeFrame: Duration of procedure (minutes)
measure: Need for additional airway equipment
timeFrame: Duration of procedure (minutes)
measure: Need to change the device for intubation
timeFrame: Duration of procedure (minutes)
measure: Complications of tracheal intubation
timeFrame: Duration of procedure (minutes)
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University Clinical Hospital of Santiago de Compostela
state: A Coruña
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario de A Coruña
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau, Barcelona
city: Cáceres
country: Spain
facility: Hospital Universitario de Cáceres
city: Denia
country: Spain
facility: Hospital de Denia
city: Elche
country: Spain
facility: Hospital General Universitario de Eche
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes, Gijón
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves, Granada
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti, Lugo
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Paz, Madrid
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro, Majadahonda
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA), Oviedo
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra, Pamplona
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia, San Sebastián
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla, Santander
city: Segovia
country: Spain
facility: Complejo Asistencial de Segovia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe de Valencia
city: Vigo
country: Spain
facility: Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo
city: Vigo
country: Spain
facility: Hospital Ribera Povisa Vigo
Study officials:
affiliation: University Clinical Hospital of Santiago de Compostela
name: Manuel Taboada, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz DR, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE Investigators and the Pragmatic Critical Care Research Group. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2023 Aug 3;389(5):418-429. doi: 10.1056/NEJMoa2301601. Epub 2023 Jun 16.
citation: 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. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.
citation: 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 Anaesth. 2023 Sep;131(3):607-616. doi: 10.1016/j.bja.2023.04.022. Epub 2023 May 17.
citation: 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.
citation: 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.
citation: 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.