Macintosh Blade Size for Endotracheal Intubation in Operative Rooms

NCT06232837 | Completed

• 1 other identifier: IRB 00010254-2023-081
• Study Type: observational
• Target: 3,058
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intubation; Difficult or Failed; Intubation Complication; Endotracheal Intubation

Keywords

Intubation; Operative Room; Macintosh; Direct Laryngoscopy; Video Laryngoscopy; Complications

Outcome Measures

Primary Outcomes (1)

• Number of patients with successful first-pass orotracheal intubation

  The proportion of patients with successful first-pass orotracheal intubation

  At intubation

Secondary Outcomes (15)

• Severe complications related to intubation_hypoxemia

  At intubation

• Severe complications related to intubation_severe collapse

  At intubation

• Severe complications related to intubation_cardiac arrest

  At intubation

• Severe complications related to intubation_death

  At intubation

• Moderate complications related to intubation_difficult intubation

  At intubation

Study Arms (2)

Macintosh blade size 3

Patients intubated using Macintosh blade size 3

Device: Direct laryngoscopy using Macintosh blade

Macintosh blade size 4

Patients intubated using Macintosh blade size 4

Device: Direct laryngoscopy using Macintosh blade

Interventions

Direct laryngoscopy using Macintosh blade DEVICE

Patients in operative room requiring direct laryngoscopy for endotracheal intubation

Macintosh blade size 3; Macintosh blade size 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient requiring orotracheal intubation with direct laryngoscopy in first place

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Société Française d'Anesthésie-Réanimation (SFAR): collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Related 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.

  PMID: 35974189 BACKGROUND

• 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.

  PMID: 36895888 BACKGROUND

Study Officials

• Thomas Godet, MD, PhD

  Clermont-Ferrand University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 31, 2024
• Study Start: January 22, 2024
• Primary Completion: September 20, 2025
• Study Completion: September 20, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data available after study completion and publication

Locations

FR (1)