Clinical trial NCT05059067: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.
Official title: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endotracheal Intubation
Keywords: Intubation
Macintosh blade
Laryngoscopie
Operative room
Intensive Care Unit
Emergency department
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient requiring orotracheal intubation with direct laryngoscopy

Brief summary: 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with successful first-pass orotracheal intubation
timeFrame: At intubation
Secondary outcomes:
measure: Severe complications related to intubation_hypoxemia
timeFrame: At intubation
measure: Severe complications related to intubation_severe collapse
timeFrame: At intubation
measure: Severe complications related to intubation_cardiac arrest
timeFrame: At intubation
measure: Severe complications related to intubation_death
timeFrame: At intubation
measure: Moderate complications related to intubation_difficult intubation
timeFrame: At intubation
measure: Moderate complications related to intubation_arrythmia
timeFrame: At intubation
measure: Moderate complications related to intubation_oesophageal intubation
timeFrame: At intubation
measure: Moderate complications related to intubation_agitation
timeFrame: At intubation
measure: Moderate complications related to intubation_aspiration
timeFrame: At intubation
measure: Moderate complications related to intubation_dental injuries
timeFrame: At intubation
measure: Cormack Lehane
timeFrame: During intubation
measure: Difficulty of intubation
timeFrame: During intubation
measure: Additional airway equipment
timeFrame: During intubation
measure: Additional second operator
timeFrame: During intubation
measure: POGO (percentage of glottic opening)
timeFrame: During intubation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Thomas Godet
role: PRINCIPAL_INVESTIGATOR
References: