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Intubation ComplicationMacSize_ORNCT06232837

Macintosh Blade Size for Endotracheal Intubation in Operative Rooms

An observational study of Intubation Complication and Intubation; Difficult or Failed, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

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

Official record
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Trial summary

Endotracheal intubation is a frequent procedure in the operating room but optimal Macintosh blade size remains unknown to date. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Direct laryngoscopy using Macintosh blade
Type of treatment
Medical device
How many people
3,058 participants
Where
1 siteFrance
Study dates
22 Jan 2024to 20 Sep 2025
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any patient requiring orotracheal intubation with direct laryngoscopy in first place

Who may be able to join

  • Patients must be admitted in a participating operative room and require mechanical ventilation through an orotracheal tube.
  • Adult (age ≥ 18 years)
  • Subjects must be covered by public health insurance
  • Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Who cannot join

  • Anticipated difficult intubation requiring videolaryngoscopy or other technic in first place
  • Nasotracheal intubation
  • Refusal of study participation or to pursue the study by the patient
  • Absence of coverage by the French statutory healthcare insurance system
  • Protected person

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000

Other trials in France

About this study

Official title: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation in Operative Rooms. A Nationwide Prospective Observational Study.

Endotracheal intubation is a frequent procedure in the operating room but optimal Macintosh blade size remains unknown to date.

Read the detailed description

Endotracheal intubation is an extremely frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital). Apart from special cases of foreseen difficult programmed intubation, direct laryngoscopy remains the most frequently used technique. It requires the use of a handle (short or long), which serves as a light source on which is adapted a Macintosh curved blade, metallic or plastic, single or multiple use. The choice of blade size is based on the experience of the physician. Most often, in adult settings, size 3 or 4 blades are used. The very spartan literature on the subject and the current recommendations do not provide any information on the choice of blade size. Our team (and others) recently concluded that intubation first attempt rates in intensive care units or emergency settings were improved when using shorter Macintosh blade size No3 vs 4 (Godet et al. Intensive Care Medicine 2022 and Landefeld et al. Critical Care Explorations 2023). We therefore wish to evaluate these practices in terms of success of the first laryngoscopy, Cormack-Lehane and POGO (percentage of glottic opening visualized) scores, the need to use an alternative technique or a second operator in operative rooms. The results will be analyzed with regard as a function and experience of the person performing the laryngoscopy, as well as the setting (urgent or scheduled). These data are usually collected during the performance of an endotracheal intubation in a nationwide fashion in French operative rooms.

Being tested
Direct laryngoscopy using Macintosh blade
Keywords
Intubation, Operative Room, Macintosh, Direct Laryngoscopy, Video Laryngoscopy, Complications

What participants receive

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

  • Direct laryngoscopy using Macintosh bladeDevice

    Patients in operative room requiring direct laryngoscopy for endotracheal intubation

Study groups in NCT06232837
Study groupRoleWhat they receive
Macintosh blade size 3Patients intubated using Macintosh blade size 3
Receives: Device: Direct laryngoscopy using Macintosh blade
Macintosh blade size 4Patients intubated using Macintosh blade size 4
Receives: Device: Direct laryngoscopy using Macintosh blade

What is being measured

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

  1. Number of patients with successful first-pass orotracheal intubation

    The proportion of patients with successful first-pass orotracheal intubation

    Measured: At intubation

Secondary outcomes (15)

  1. Severe complications related to intubation_hypoxemia

    Rate of severe hypoxemia defined by lowest oxygen saturation (SpO2) < 90 %

    Measured: At intubation

  2. Severe complications related to intubation_severe collapse

    Rate of cardiovascular collapse, defined as systolic blood pressure less than 80 mmHg systolic blood pressure less than 50 mmHg recorded at least once

    Measured: At intubation

  3. Severe complications related to intubation_cardiac arrest

    Rate of cardiac arrest related to intubation

    Measured: At intubation

  4. Severe complications related to intubation_death

    Rate of death related to intubation

    Measured: At intubation

  5. Moderate complications related to intubation_difficult intubation

    Rate of difficult intubation

    Measured: At intubation

  6. Moderate complications related to intubation_arrythmia

    Rate of severe ventricular or supraventricular arrhythmia requiring intervention

    Measured: At intubation

  7. Moderate complications related to intubation_oesophageal intubation

    Rate of oesophageal intubation

    Measured: At intubation

  8. Moderate complications related to intubation_agitation

    Rate of agitation

    Measured: At intubation

  9. Moderate complications related to intubation_aspiration

    Rate of pulmonary aspiration

    Measured: At intubation

  10. Moderate complications related to intubation_dental injuries

    Rate of dental injuries

    Measured: At intubation

  11. Cormack Lehane

    Cormack-Lehane grade of glottic view

    Measured: During laryngoscopy

  12. Percentage of Glottic Opening

    Percentage of Glottic Opening (POGO) grade of glottic view

    Measured: During laryngoscopy

  13. Difficulty of intubation

    Rate of operator-assessed difficulty of intubation

    Measured: During intubation

  14. Additional airway equipment

    Rate of need for additional airway equipment (video laryngoscope, bougie, stylet, fibroscope, cricothyrotomy)

    Measured: During intubation

  15. Additional second operator

    Rate of need for a second operator

    Measured: During intubation

Timeline

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

  1. First posted31 Jan 2024
  2. Study start22 Jan 2024
  3. Primary completion20 Sep 2025
  4. Study completion20 Sep 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
3,058 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232837
Sponsor's protocol ID
IRB 00010254-2023-081
Acronym
MacSize_OR
Status last verified
Nov 2025
First submitted
10 Jan 2024
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data available upon reasonable request and satisfactory presented analysis plan. Authorship will include principal investigator (last author).

Publications

  • Godet T, De Jong A, Garin C, Guerin R, Rieu B, Borao L, Pereira B, Molinari N, Bazin JE, Jabaudon M, Chanques G, Futier E, Jaber S. Impact of Macintosh blade size on endotracheal intubation success in intensive care units: a retrospective multicenter observational MacSize-ICU study. Intensive Care Med. 2022 Sep;48(9):1176-1184. doi: 10.1007/s00134-022-06832-9. Epub 2022 Aug 16.

    PubMed 35974189

  • Landefeld KR, Koike S, Ran R, Semler MW, Barnes C, Stempek SB, Janz DR, Rice TW, Russell DW, Self WH, Vonderhaar D, West JR, Casey JD, Khan A. Effect of Laryngoscope Blade Size on First Pass Success of Tracheal Intubation in Critically Ill Adults. Crit Care Explor. 2023 Mar 6;5(3):e0855. doi: 10.1097/CCE.0000000000000855. eCollection 2023 Mar.

    PubMed 36895888

Questions about this trial

What is this clinical trial studying?

An observational study of Intubation Complication and Intubation; Difficult or Failed, run by University Hospital, Clermont-Ferrand at 1 site in France.

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 5 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 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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?

Number of patients with successful first-pass orotracheal intubation (time frame: At intubation). 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 NCT06232837, which also lists 2 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 2 Feb 2026.

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