Clinical trial NCT06232837: Macintosh Blade Size for Endotracheal Intubation in Operative Rooms
Official title: Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation in Operative Rooms. A Nationwide Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intubation Complication
Intubation; Difficult or Failed
Endotracheal Intubation
Keywords: Intubation
Operative Room
Macintosh
Direct Laryngoscopy
Video Laryngoscopy
Complications
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie-Réanimation (SFAR)
First posted: 2024-01-31
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient requiring orotracheal intubation with direct laryngoscopy in first place

Brief summary: Endotracheal intubation is a frequent procedure in the operating room 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. 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.

Eligibility criteria: 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

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 laryngoscopy
measure: Percentage of Glottic Opening
timeFrame: During laryngoscopy
measure: Difficulty of intubation
timeFrame: During intubation
measure: Additional airway equipment
timeFrame: During intubation
measure: Additional second operator
timeFrame: During intubation
Other outcomes:
Locations:
Study officials:
affiliation: Clermont-Ferrand University Hospitals
name: Thomas Godet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.