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

NCT05059067 | Unknown

• 1 other identifier: IRB 00010254-2021-016
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotracheal Intubation

Keywords

Intubation; Macintosh blade; Laryngoscopie; Operative room; Intensive Care Unit; Emergency department

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 for endotracheal intubation

Macintosh blade size 4

Patients intubated using Macintosh blade size 4

Device: Direct laryngoscopy for endotracheal intubation

Interventions

Direct laryngoscopy for endotracheal intubation DEVICE

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

Macintosh blade size 3; Macintosh blade size 4

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient requiring orotracheal intubation with direct laryngoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Officials

• Thomas Godet

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

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

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: September 28, 2021
• Study Start: June 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-06

Locations

FR (1)