Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

Not Applicable

Recruiting

• Conditions: Intubation; Difficult or Failed; Videolaryngoscopy; Acute Respiratory Failure; Intubation; Intubation Complication
• Interventions: Device: Macintosh blade videolaryngoscope; Device: Hyperangulated blade videolaryngoscope

• Registration Number: NCT06322719
• Lead Sponsor: Hospital Clinico Universitario de Santiago

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.

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-20
• Study First Posted: 2024-03-21
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1036

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Macintosh videolaryngoscope	Macintosh blade videolaryngoscope	Tracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade
Hyperangulated videolaryngoscope	Hyperangulated blade videolaryngoscope	Tracheal intubation facilitated by a hyperangulated videolaryngoscope

Primary Outcome Measures

Name	Time	Method
Difference in the first attempt intubation success rate (percentage)	During intubation (minutes)	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.

Secondary Outcome Measures

Name	Time	Method
Number of intubation attempts	During intubation (minutes)	To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes
Need for additional airway equipment	Duration of procedure (minutes)	Airway equipment: bougie, stylet, other videolaryngoscope, others
Difference in the overall success rate	During intubation (minutes)	To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes
Number of videolaryngoscopy attempts	Duration of procedure (minutes)	To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation
Modified Cormack-Lehane grade of glottic view	During intubation (minutes)	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
Diference in the incidence of "easy intubation"	During intubation (minutes)	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.
Complications of tracheal intubation	Duration of procedure (minutes)	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 tracheal intubation	Duration of procedure (minutes)	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.
Number of attempts to cannulate the trachea with a bougie or an endotracheal tube	Duration of procedure (minutes)	To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube
Need to change the device for intubation	Duration of procedure (minutes)	Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).
Operator-assessed difficulty of intubation	Duration of procedure (minutes)	To compare operator-assessed subjective difficulty of intubation: * without difficulty; * mild difficulty; * moderate difficulty; * severe difficulty
Reason for unsuccessful intubation on the first attempt	Duration of procedure (minutes)	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

Trial Locations

Locations (29)

Hospital Gregorio Marañón, Madrid; 🇪🇸 Madrid, Spain

Hospital de Denia; 🇪🇸 Denia, Spain

Hospital Universitario de Cáceres; 🇪🇸 Cáceres, Spain

Hospital General de Albacete; 🇪🇸 Albacete, Spain

Complejo Asistencial Universitario de León; 🇪🇸 León, Spain

Hospital Universitario Donostia, San Sebastián; 🇪🇸 San Sebastián, Spain

Hospital General Universitario de Eche; 🇪🇸 Elche, Spain

Hospital de la Santa Creu i Sant Pau, Barcelona; 🇪🇸 Barcelona, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Complejo Asistencial de Segovia; 🇪🇸 Segovia, Spain

Hospital Virgen de las Nieves, Granada; 🇪🇸 Granada, Spain

Hospital Universitario de Gran Canaria Doctor Negrín; 🇪🇸 Las Palmas De Gran Canaria, Spain

Hospital Universitario Central de Asturias (HUCA), Oviedo; 🇪🇸 Oviedo, Spain

Hospital Universitario Puerta de Hierro, Majadahonda; 🇪🇸 Majadahonda, Spain

Clínica Universidad de Navarra, Pamplona; 🇪🇸 Pamplona, Spain

Complexo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario de Cabueñes, Gijón; 🇪🇸 Gijón, Spain

Hospital Ribera Povisa Vigo; 🇪🇸 Vigo, Spain

Hospital Universitario 12 de Octubre, Madrid; 🇪🇸 Madrid, Spain

Hospital Universitario Lucus Augusti, Lugo; 🇪🇸 Lugo, Spain

Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz, Madrid; 🇪🇸 Madrid, Spain

Hospital Universitario de Móstoles; 🇪🇸 Móstoles, Spain

Complexo Hospitalario Universitario de Ourense; 🇪🇸 Ourense, Spain

Complexo Hospitalario Universitario de Pontevedra; 🇪🇸 Pontevedra, Spain

Hospital Universitario La Fe de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Marqués de Valdecilla, Santander; 🇪🇸 Santander, Spain

Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo; 🇪🇸 Vigo, Spain

University Clinical Hospital of Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruña, Spain