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Completed

NCT Number: NCT06232837

Macintosh Blade Size for Endotracheal Intubation in Operative Rooms

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Direct laryngoscopy using Macintosh blade

Device

Patients in operative room requiring direct laryngoscopy for endotracheal intubation

Primary outcomes

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

    Time frame: At intubation

    The proportion of patients with successful first-pass orotracheal intubation

Secondary outcomes

  1. Severe complications related to intubation_hypoxemia

    Time frame: At intubation

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

  2. Severe complications related to intubation_severe collapse

    Time frame: At intubation

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

  3. Severe complications related to intubation_cardiac arrest

    Time frame: At intubation

    Rate of cardiac arrest related to intubation

  4. Severe complications related to intubation_death

    Time frame: At intubation

    Rate of death related to intubation

  5. Moderate complications related to intubation_difficult intubation

    Time frame: At intubation

    Rate of difficult intubation

  6. Moderate complications related to intubation_arrythmia

    Time frame: At intubation

    Rate of severe ventricular or supraventricular arrhythmia requiring intervention

  7. Moderate complications related to intubation_oesophageal intubation

    Time frame: At intubation

    Rate of oesophageal intubation

  8. Moderate complications related to intubation_agitation

    Time frame: At intubation

    Rate of agitation

  9. Moderate complications related to intubation_aspiration

    Time frame: At intubation

    Rate of pulmonary aspiration

  10. Moderate complications related to intubation_dental injuries

    Time frame: At intubation

    Rate of dental injuries

  11. Cormack Lehane

    Time frame: During laryngoscopy

    Cormack-Lehane grade of glottic view

  12. Percentage of Glottic Opening

    Time frame: During laryngoscopy

    Percentage of Glottic Opening (POGO) grade of glottic view

  13. Difficulty of intubation

    Time frame: During intubation

    Rate of operator-assessed difficulty of intubation

  14. Additional airway equipment

    Time frame: During intubation

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

  15. Additional second operator

    Time frame: During intubation

    Rate of need for a second operator

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Société Française d'Anesthésie-Réanimation (SFAR)

Registry information

Official study title

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

Acronym: MacSize_OR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 31, 2024
Registry last updated
Feb 2, 2026

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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