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Acute Respiratory FailureINVIBLADENCT06322719

Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU

A study testing Hyperangulated blade videolaryngoscope and Macintosh blade videolaryngoscope in people with Acute Respiratory Failure and Intubation, run by Hospital Clinico Universitario de Santiago at 29 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Hyperangulated blade videolaryngoscope and Macintosh blade videolaryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,036 participants
Where
29 sitesSpain
Study dates
1 May 2024to 20 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.).

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Spain29 sites

  • Complexo Hospitalario Universitario de A Coruña

    A Coruña

  • Hospital General de Albacete

    Albacete

  • Hospital de la Santa Creu i Sant Pau, Barcelona

    Barcelona

  • Hospital Universitario de Cáceres

    Cáceres

  • Hospital de Denia

    Denia

  • Hospital General Universitario de Eche

    Elche

  • Hospital Universitario de Cabueñes, Gijón

    Gijón

  • Hospital Virgen de las Nieves, Granada

    Granada

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria

  • Complejo Asistencial Universitario de León

    León

  • Hospital Universitario Lucus Augusti, Lugo

    Lugo

  • Hospital Gregorio Marañón, Madrid

    Madrid

  • Hospital Universitario 12 de Octubre, Madrid

    Madrid

  • Hospital Universitario La Paz, Madrid

    Madrid

  • Hospital Universitario La Princesa

    Madrid

  • Hospital Universitario Puerta de Hierro, Majadahonda

    Majadahonda

  • Hospital Universitario de Móstoles

    Móstoles

  • Complexo Hospitalario Universitario de Ourense

    Ourense

  • Hospital Universitario Central de Asturias (HUCA), Oviedo

    Oviedo

  • Clínica Universidad de Navarra, Pamplona

    Pamplona

  • Complexo Hospitalario Universitario de Pontevedra

    Pontevedra

  • Hospital Universitario Donostia, San Sebastián

    San Sebastián

  • Hospital Universitario Marqués de Valdecilla, Santander

    Santander

  • University Clinical Hospital of Santiago de Compostela

    Santiago de Compostela, A Coruña, 15866

  • Complejo Asistencial de Segovia

    Segovia

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitario La Fe de Valencia

    Valencia

  • Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo

    Vigo

  • Hospital Ribera Povisa Vigo

    Vigo

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Hyperangulated blade videolaryngoscope, Macintosh blade videolaryngoscope
Keywords
videolaryngoscopy, tracheal intubation, complication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperangulated blade videolaryngoscopeDevice

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

  • Macintosh blade videolaryngoscopeDevice

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

Study groups in NCT06322719
Study groupRoleWhat they receive
Hyperangulated videolaryngoscopeExperimentalTracheal intubation facilitated by a hyperangulated videolaryngoscope
Receives: Device: Hyperangulated blade videolaryngoscope
Macintosh videolaryngoscopeActive comparatorTracheal intubation facilitated by a videolaryngoscope with a Macintosh type blade
Receives: Device: Macintosh blade videolaryngoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: During intubation (minutes)

Secondary outcomes (12)

  1. Difference in the overall success rate

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

    Measured: During intubation (minutes)

  2. Number of intubation attempts

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

    Measured: During intubation (minutes)

  3. 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

    Measured: During intubation (minutes)

  4. 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.

    Measured: During intubation (minutes)

  5. 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.

    Measured: Duration of procedure (minutes)

  6. 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

    Measured: Duration of procedure (minutes)

  7. Number of videolaryngoscopy attempts

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

    Measured: Duration of procedure (minutes)

  8. 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

    Measured: Duration of procedure (minutes)

  9. Operator-assessed difficulty of intubation

    To compare operator-assessed subjective difficulty of intubation:

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

    Measured: Duration of procedure (minutes)

  10. Need for additional airway equipment

    Airway equipment: bougie, stylet, other videolaryngoscope, others

    Measured: Duration of procedure (minutes)

  11. Need to change the device for intubation

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

    Measured: Duration of procedure (minutes)

  12. 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

    Measured: Duration of procedure (minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start1 May 2024
  3. Primary completion20 Sep 2026
  4. Study completion20 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,036 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322719
Sponsor's protocol ID
INVIBLADE
Acronym
INVIBLADE
Status last verified
Oct 2026
First submitted
14 Mar 2024
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 29406182

  • 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.

    PubMed 37326325

  • 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.

    PubMed 33755076

  • 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.

    PubMed 37208282

  • 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.

    PubMed 35820934

  • 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.

    PubMed 38167459

  • 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.

    PubMed 29787386

  • 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.

    PubMed 39237284

Questions about this trial

What is this clinical trial studying?

A study testing Hyperangulated blade videolaryngoscope and Macintosh blade videolaryngoscope in people with Acute Respiratory Failure and Intubation, run by Hospital Clinico Universitario de Santiago at 29 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the first attempt intubation success rate (percentage) (time frame: During intubation (minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322719, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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