Macintosh Blade Size for Endotracheal Intubation in Operative Rooms

Intubation Complication Clinical Trial

— MacSize_OR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232837
• Other study ID #: IRB 00010254-2023-081
• Status: Not yet recruiting
• Start date: February 1, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: Thomas Godet, MD, PhD
• Phone: +33473755170
• Email: tgodet[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation
• Intubation Complication
• Intubation; Difficult or Failed

Intervention

Device:
• Direct laryngoscopy using Macintosh blade
Patients in operative room requiring direct laryngoscopy for endotracheal intubation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Société Française d'Anesthésie-Réanimation (SFAR)

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with successful first-pass orotracheal intubation	The proportion of patients with successful first-pass orotracheal intubation	At intubation
Secondary	Severe complications related to intubation_hypoxemia	Rate of severe hypoxemia defined by lowest oxygen saturation (SpO2) < 90 %	At intubation
Secondary	Severe complications related to intubation_severe collapse	Rate of cardiovascular collapse, defined as systolic blood pressure less than 80 mmHg systolic blood pressure less than 50 mmHg recorded at least once	At intubation
Secondary	Severe complications related to intubation_cardiac arrest	Rate of cardiac arrest related to intubation	At intubation
Secondary	Severe complications related to intubation_death	Rate of death related to intubation	At intubation
Secondary	Moderate complications related to intubation_difficult intubation	Rate of difficult intubation	At intubation
Secondary	Moderate complications related to intubation_arrythmia	Rate of severe ventricular or supraventricular arrhythmia requiring intervention	At intubation
Secondary	Moderate complications related to intubation_oesophageal intubation	Rate of oesophageal intubation	At intubation
Secondary	Moderate complications related to intubation_agitation	Rate of agitation	At intubation
Secondary	Moderate complications related to intubation_aspiration	Rate of pulmonary aspiration	At intubation
Secondary	Moderate complications related to intubation_dental injuries	Rate of dental injuries	At intubation
Secondary	Cormack Lehane	Cormack-Lehane grade of glottic view	During laryngoscopy
Secondary	Percentage of Glottic Opening	Percentage of Glottic Opening (POGO) grade of glottic view	During laryngoscopy
Secondary	Difficulty of intubation	Rate of operator-assessed difficulty of intubation	During intubation
Secondary	Additional airway equipment	Rate of need for additional airway equipment (video laryngoscope, bougie, stylet, fibroscope, cricothyrotomy)	During intubation
Secondary	Additional second operator	Rate of need for a second operator	During intubation