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NCT Number: NCT06322719

Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinical Hospital of Santiago de Compostela, Santiago de Compostela, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

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.

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.

Primary outcomes

  1. Difference in the first attempt intubation success rate (percentage)

    Time frame: 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 outcomes

  1. Difference in the overall success rate

    Time frame: During intubation (minutes)

    To compare the difference overall success rate (percentage) with the two (hyperangulated vs Macintosh blades) videolaryngoscopes

  2. Number of intubation attempts

    Time frame: During intubation (minutes)

    To compare number of intubations attempts with the two (hyperangulated vs Macintosh blades) videolaryngoscopes

  3. Modified Cormack-Lehane grade of glottic view

    Time frame: 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

  4. Diference in the incidence of "easy intubation"

    Time frame: 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.

  5. Duration of tracheal intubation

    Time frame: 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.

  6. Reason for unsuccessful intubation on the first attempt

    Time frame: 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

  7. Number of videolaryngoscopy attempts

    Time frame: Duration of procedure (minutes)

    To compare the number of videolaryngoscope attempts neccesary to successfull tracheal intubation

  8. Number of attempts to cannulate the trachea with a bougie or an endotracheal tube

    Time frame: Duration of procedure (minutes)

    To compare the number of attempts to cannulate the trachea with a bougie or an endotracheal tube

  9. Operator-assessed difficulty of intubation

    Time frame: Duration of procedure (minutes)

    To compare operator-assessed subjective difficulty of intubation:

    • without difficulty
    • mild difficulty
    • moderate difficulty
    • severe difficulty

  10. Need for additional airway equipment

    Time frame: Duration of procedure (minutes)

    Airway equipment: bougie, stylet, other videolaryngoscope, others

  11. Need to change the device for intubation

    Time frame: Duration of procedure (minutes)

    Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope...).

  12. Complications of tracheal intubation

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Taboada

CONTACT

[email protected]

678195618

Manuel Taboada, Ph.D.

CONTACT

[email protected]

678195618

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

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

Acronym: INVIBLADE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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