Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Acute Respiratory Failure Clinical Trial

— INVIBLADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322719
• Other study ID #: INVIBLADE
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Hospital Clinico Universitario de Santiago
• Contact: Manuel Taboada, Ph.D.
• Phone: 678195618
• Email: manutabo[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1036
• Est. completion date: May 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Spain	Complexo Hospitalario Universitario de A Coruña	A Coruña
Spain	Hospital General de Albacete	Albacete
Spain	Hospital de la Santa Creu i Sant Pau, Barcelona	Barcelona
Spain	Hospital Universitario de Cáceres	Cáceres
Spain	Hospital de Denia	Denia
Spain	Hospital General Universitario de Eche	Elche
Spain	Hospital Universitario de Cabueñes, Gijón	Gijón
Spain	Hospital Virgen de las Nieves, Granada	Granada
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas De Gran Canaria
Spain	Complejo Asistencial Universitario de León	León
Spain	Hospital Universitario Lucus Augusti, Lugo	Lugo
Spain	Hospital Gregorio Marañón, Madrid	Madrid
Spain	Hospital Universitario 12 de Octubre, Madrid	Madrid
Spain	Hospital Universitario La Paz, Madrid	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda	Majadahonda
Spain	Hospital Universitario de Móstoles	Móstoles
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Universitario Central de Asturias (HUCA), Oviedo	Oviedo
Spain	Clínica Universidad de Navarra, Pamplona	Pamplona
Spain	Complexo Hospitalario Universitario de Pontevedra	Pontevedra
Spain	Hospital Universitario Donostia, San Sebastián	San Sebastián
Spain	Hospital Universitario Marqués de Valdecilla, Santander	Santander
Spain	University Clinical Hospital of Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Complejo Asistencial de Segovia	Segovia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario La Fe de Valencia	Valencia
Spain	Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo	Vigo
Spain	Hospital Ribera Povisa Vigo	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: JAMA. 2021 May 24;:null. — View 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. Anes — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Number of intubation attempts	To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes	During intubation (minutes)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of videolaryngoscopy attempts	To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation	Duration of procedure (minutes)
Secondary	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)
Secondary	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)
Secondary	Need for additional airway equipment	Airway equipment: bougie, stylet, other videolaryngoscope, others	Duration of procedure (minutes)
Secondary	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)
Secondary	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)