Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

NCT06322719 | Recruiting

• 1 other identifier: INVIBLADE
• Study Type: interventional
• Target: 1,036
• Locations: 1 country
• Sites: 29

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.

Conditions

Acute Respiratory Failure; Intubation; Intubation; Difficult or Failed; Videolaryngoscopy; Intubation Complication

Keywords

videolaryngoscopy; tracheal intubation; complication

Outcome Measures

Primary Outcomes (1)

• Difference in the first attempt intubation success rate (percentage)

  The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a videolaryngoscope 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.

  During intubation (minutes)

Secondary Outcomes (12)

• Difference in the overall success rate

  During intubation (minutes)

• Number of intubation attempts

  During intubation (minutes)

• Modified Cormack-Lehane grade of glottic view

  During intubation (minutes)

• Diference in the incidence of "easy intubation"

  During intubation (minutes)

• Duration of tracheal intubation

  Duration of procedure (minutes)

Study Arms (2)

Hyperangulated videolaryngoscope

EXPERIMENTAL

Tracheal intubation facilitated by a hyperangulated videolaryngoscope

Device: Hyperangulated blade videolaryngoscope

Macintosh videolaryngoscope

ACTIVE COMPARATOR

Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade

Device: Macintosh blade videolaryngoscope

Interventions

Hyperangulated blade videolaryngoscope DEVICE

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

Hyperangulated videolaryngoscope

Macintosh blade videolaryngoscope DEVICE

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

Macintosh videolaryngoscope

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (29)

University Clinical Hospital of Santiago de Compostela

Santiago de Compostela, A Coruña, 15866, Spain

RECRUITING

Complexo Hospitalario Universitario de A Coruña

A Coruña, Spain

RECRUITING

Hospital General de Albacete

Albacete, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario de Cáceres

Cáceres, Spain

NOT YET RECRUITING

Hospital de Denia

Denia, Spain

NOT YET RECRUITING

Hospital General Universitario de Eche

Elche, Spain

NOT YET RECRUITING

Hospital Universitario de Cabueñes, Gijón

Gijón, Spain

NOT YET RECRUITING

Hospital Virgen de las Nieves, Granada

Granada, Spain

NOT YET RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

NOT YET RECRUITING

Complejo Asistencial Universitario de León

León, Spain

NOT YET RECRUITING

Hospital Universitario Lucus Augusti, Lugo

Lugo, Spain

RECRUITING

Hospital Gregorio Marañón, Madrid

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre, Madrid

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario La Paz, Madrid

Madrid, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro, Majadahonda

Majadahonda, Spain

NOT YET RECRUITING

Hospital Universitario de Móstoles

Móstoles, Spain

NOT YET RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

NOT YET RECRUITING

Hospital Universitario Central de Asturias (HUCA), Oviedo

Oviedo, Spain

NOT YET RECRUITING

Clínica Universidad de Navarra, Pamplona

Pamplona, Spain

NOT YET RECRUITING

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

NOT YET RECRUITING

Hospital Universitario Donostia, San Sebastián

San Sebastián, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

Santander, Spain

NOT YET RECRUITING

Complejo Asistencial de Segovia

Segovia, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

NOT YET RECRUITING

Hospital Universitario La Fe de Valencia

Valencia, Spain

NOT YET RECRUITING

Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo

Vigo, Spain

NOT YET RECRUITING

Hospital Ribera Povisa Vigo

Vigo, Spain

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 37326325 BACKGROUND

• 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.

  PMID: 33755076 BACKGROUND

• 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.

  PMID: 37208282 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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, Cabaleiro T. Hyperangulated versus Macintosh blades for intubation with videolaryngoscopy in ICU: the randomised multicentre INVIBLADE-ICU trial study protocol. BMJ Open. 2024 Sep 5;14(9):e086691. doi: 10.1136/bmjopen-2024-086691.

  PMID: 39237284 DERIVED

Study Officials

• Manuel Taboada, Ph.D.

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Taboada, Ph.D.

CONTACT

678195618; manutabo@yahoo.es

Manuel Taboada

CONTACT

678195618; manuel.taboada.muniz@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anesthesiology

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (29)