Macintosh Blade Size for Endotracheal Intubation in Operative Rooms

Not yet recruiting

• Conditions: Intubation; Difficult or Failed; Intubation Complication; Endotracheal Intubation
• Interventions: Device: Direct laryngoscopy using Macintosh blade

• Registration Number: NCT06232837
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-22
• Last Update Submitted: 2024-01-22
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Study Start: 2024-02-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Macintosh blade size 3	Direct laryngoscopy using Macintosh blade	Patients intubated using Macintosh blade size 3
Macintosh blade size 4	Direct laryngoscopy using Macintosh blade	Patients intubated using Macintosh blade size 4

Primary Outcome Measures

Name	Time	Method
Number of patients with successful first-pass orotracheal intubation	At intubation	The proportion of patients with successful first-pass orotracheal intubation

Secondary Outcome Measures

Name	Time	Method
Moderate complications related to intubation_aspiration	At intubation	Rate of pulmonary aspiration
Moderate complications related to intubation_dental injuries	At intubation	Rate of dental injuries
Severe complications related to intubation_death	At intubation	Rate of death related to intubation
Moderate complications related to intubation_difficult intubation	At intubation	Rate of difficult intubation
Moderate complications related to intubation_agitation	At intubation	Rate of agitation
Severe complications related to intubation_hypoxemia	At intubation	Rate of severe hypoxemia defined by lowest oxygen saturation (SpO2) \< 90 %
Severe complications related to intubation_severe collapse	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
Severe complications related to intubation_cardiac arrest	At intubation	Rate of cardiac arrest related to intubation
Moderate complications related to intubation_arrythmia	At intubation	Rate of severe ventricular or supraventricular arrhythmia requiring intervention
Moderate complications related to intubation_oesophageal intubation	At intubation	Rate of oesophageal intubation
Cormack Lehane	During laryngoscopy	Cormack-Lehane grade of glottic view
Difficulty of intubation	During intubation	Rate of operator-assessed difficulty of intubation
Additional second operator	During intubation	Rate of need for a second operator
Percentage of Glottic Opening	During laryngoscopy	Percentage of Glottic Opening (POGO) grade of glottic view
Additional airway equipment	During intubation	Rate of need for additional airway equipment (video laryngoscope, bougie, stylet, fibroscope, cricothyrotomy)