Macintosh Blade Size During Laryngoscopy for Endotracheal Intubation. A Prospective Observational Study.

NCT ID: NCT05059067

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2022-01-01

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.

Conditions

Endotracheal Intubation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Macintosh blade size 3

Patients intubated using Macintosh blade size 3

Direct laryngoscopy for endotracheal intubation

Intervention Type: DEVICE

Patients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation

Macintosh blade size 4

Patients intubated using Macintosh blade size 4

Direct laryngoscopy for endotracheal intubation

Intervention Type: DEVICE

Patients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation

Interventions

Direct laryngoscopy for endotracheal intubation

Patients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Godet

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33 4 73 754963

Facility Contacts

Thomas Godet

Role: primary

tgodet@chu-clermontferrand.fr

Other Identifiers

IRB 00010254-2021-016

Identifier Type: -

Identifier Source: org_study_id