Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU (INVIBLADE)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intubation; Intubation Complication; Intubation; Difficult or Failed; Acute Respiratory Failure; Videolaryngoscopy
• Intervention / Treatment: Device: Hyperangulated blade videolaryngoscope; Device: Macintosh blade videolaryngoscope

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.

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel Taboada, Ph.D.; Phone Number: 678195618; Email: manutabo@yahoo.es
• Study Contact Backup: Name: Manuel Taboada; Phone Number: 678195618; Email: manuel.taboada.muniz@sergas.es

Study Locations

• Spain
  • A Coruña, Spain
    • Complexo Hospitalario Universitario de A Coruña
    • Contact: Pablo Rama; Email: Pablo.rama.maceiras@sergas.es
  • Albacete, Spain
    • Hospital General de Albacete
    • Contact: Luisa María Charco
  • Barcelona, Spain
    • Hospital de la Santa Creu i Sant Pau, Barcelona
    • Contact: Marta Giné
  • Cáceres, Spain
    • Hospital Universitario de Cáceres
    • Contact: Jose Ignacio Hermoso; Email: nachomartinez@gmail.com
  • Denia, Spain
    • Hospital de Denia
    • Contact: Marta Carrió
  • Elche, Spain
    • Hospital General Universitario de Eche
    • Contact: Ana Pérez
  • Gijón, Spain
    • Hospital Universitario de Cabueñes, Gijón
    • Contact: Rosaura María Santamarina
  • Granada, Spain
    • Hospital Virgen de las Nieves, Granada
    • Contact: Jose Luis Aguilera
  • Las Palmas De Gran Canaria, Spain
    • Hospital Universitario de Gran Canaria Doctor Negrín
    • Contact: Angel Becerra
  • León, Spain
    • Complejo Asistencial Universitario de Leon
    • Contact: Inmaculada Fernández
  • Lugo, Spain
    • Hospital Universitario Lucus Augusti, Lugo
    • Contact: María Bermúdez
  • Madrid, Spain
    • Hospital Universitario La Paz, Madrid
    • Contact: Irene Vallejo
  • Madrid, Spain
    • Hospital Universitario La Princesa
    • Contact: Fernando Ramasco
  • Madrid, Spain
    • Hospital Gregorio Marañón, Madrid
    • Contact: Mercedes Power
  • Madrid, Spain
    • Hospital Universitario 12 de Octubre, Madrid
    • Contact: Raquel García
  • Majadahonda, Spain
    • Hospital Universitario Puerta de Hierro, Majadahonda
    • Contact: Sara Del Valle
  • Móstoles, Spain
    • Hospital Universitario de Móstoles
    • Contact: Raquel Fernández
  • Ourense, Spain
    • Complexo Hospitalario Universitario de Ourense
    • Contact: María Concepción Alonso
  • Oviedo, Spain
    • Hospital Universitario Central de Asturias (HUCA), Oviedo
    • Contact: María Cristina Iglesias
  • Pamplona, Spain
    • Clinica Universidad de Navarra, Pamplona
    • Contact: Marc Vives
  • Pontevedra, Spain
    • Complexo Hospitalario Universitario de Pontevedra
    • Contact: Marina Varela
  • San Sebastián, Spain
    • Hospital Universitario Donostia, San Sebastián
    • Contact: Anxo Rubín
  • Santander, Spain
    • Hospital Universitario Marqués de Valdecilla, Santander
    • Contact: Mónica Williams
  • Segovia, Spain
    • Complejo Asistencial de Segovia
    • Contact: Francisco Javier García
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
    • Contact: Sara Martínez
  • Valencia, Spain
    • Hospital Universitario La Fe de Valencia
    • Contact: Azucena Pajares
  • Vigo, Spain
    • Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo
    • Contact: Inés María Rodríguez Naz; Email: inesnaz@gmail.com
  • Vigo, Spain
    • Hospital Ribera Povisa Vigo
    • Contact: Rafael Cabadas
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15866
      • University Clinical Hospital of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperangulated videolaryngoscope; Tracheal intubation facilitated by a hyperangulated videolaryngoscope	Device: Hyperangulated blade videolaryngoscope; For patients assigned to the Hyperangulated videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.
Active Comparator: Macintosh videolaryngoscope; Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade	Device: Macintosh blade videolaryngoscope; For patients assigned to the Macintosh videolaryngoscope Group, the operator will use a Hyperangulated video laryngoscope on the first laryngoscopy attempt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the overall success rate	To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes	During intubation (minutes)
Number of intubation attempts	To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes	During intubation (minutes)
Modified Cormack-Lehane grade of glottic view	To compare Cormack-Lehane grade of glottic view with the two (hyperangulated vs Macintosh blades) videolaryngoscopes. Modified Cormack-Lehane grade of glottic view is defined as: Grade I: full view of the glottis Grade IIa: partial view of the glottis Grade IIb: arytenoid or posterior part of the vocal cords just visible Grade III: only epiglottis visible Grade IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view	During intubation (minutes)
Diference in the incidence of "easy intubation"	To compare the difference in the incidence of "easy intubation" defined as a patient with Cormack-Lehane I-II glottic view and intubation on the first attempt.	During intubation (minutes)
Duration of tracheal intubation	To compare the interval (in seconds) between the first insertion of a videolaryngoscope blade into the mouth and the final placement of an endotracheal tube in the trachea.	Duration of procedure (minutes)
Reason for unsuccessful intubation on the first attempt	Causes of unsuccessful intubation on the first attempt: Limited visibility of the larynx; Difficulty in properly inserting the endotracheal tube; Challenges in cannulating the trachea with a bougie; Interruption of the attempt due to changes in the patient's condition (such as deteriorating hypoxemia, hypotension, bradycardia, vomiting, or bleeding); Technical malfunctions with the laryngoscope equipment (such as battery issues, light source malfunction, camera problems, or screen issues); Other factors	Duration of procedure (minutes)
Number of videolaryngoscopy attempts	To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation	Duration of procedure (minutes)
Number of attempts to cannulate the trachea with a bougie or an endotracheal tube	To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube	Duration of procedure (minutes)
Operator-assessed difficulty of intubation	To compare operator-assessed subjective difficulty of intubation: without difficulty; mild difficulty; moderate difficulty; severe difficulty	Duration of procedure (minutes)
Need for additional airway equipment	Airway equipment: bougie, stylet, other videolaryngoscope, others	Duration of procedure (minutes)
Need to change the device for intubation	Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).	Duration of procedure (minutes)
Complications of tracheal intubation	Complications: Hypoxemia (lowest oxygen saturation measured by pulse oximetry 80%-90%); Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry < 80%); Hypotension (systolic blood pressure between 80-65 mm Hg); Severe hypotension (systolic blood pressure < 65 mm Hg); Pulmonary aspiration; Esophageal intubation; Dental injuries; Airway injuries; Others	Duration of procedure (minutes)

Collaborators and Investigators

• Sponsor: Hospital Clinico Universitario de Santiago
• Investigators: Principal Investigator: Manuel Taboada, Ph.D., University Clinical Hospital of Santiago de Compostela

Publications and helpful links

General Publications

• 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. Erratum In: JAMA. 2021 May 24;:null.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Anesthesiology. 2019 Jul;131(1):222.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: complication; tracheal intubation; videolaryngoscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Dermatologic Agents; Keratolytic Agents; Pyrithione zinc
• Other Study ID Numbers: INVIBLADE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose Mechanisms of data availability: With investigator support
• IPD Sharing Time Frame: When available: With publication
• IPD Sharing Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No