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Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study. (MacSize)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Endotracheal Intubation

Treatments

Device: Direct laryngoscopy for endotracheal intubation

Study type

Observational

Funder types

Other

Identifiers

NCT05059067
IRB 00010254-2021-016

Details and patient eligibility

About

Endotracheal intubation is a frequent procedure in the operating room, in intensive care units and in emergency medicine (in- or out-of-hospital) but optimal Macintosh blade size remains unknown to date.

Full 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. 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. 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 whatever the circumstances: operating room, intensive care unit and emergency department (in-hospital) and in the SAMU-SMUR (pre-hospiatl medical service) at Clermont-Ferrand University Hospital.

Enrollment

1,500 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients must be admitted in an operative room, an intensive care unit (ICU) or an emergency department 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
  • 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 design

1,500 participants in 2 patient groups

Macintosh blade size 3
Description:
Patients intubated using Macintosh blade size 3
Treatment:
Device: Direct laryngoscopy for endotracheal intubation
Macintosh blade size 4
Description:
Patients intubated using Macintosh blade size 4
Treatment:
Device: Direct laryngoscopy for endotracheal intubation

Trial contacts and locations

1

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Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

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