Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq

NCT ID: NCT03743831

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2019-07-31

Brief Summary

News techniques of intubation by indirect laryngoscopy have arrived in operating rooms but they are still too restricted to situations (difficult intubation criteria ..). It wanted to focus on indirect laryngoscopy by Airtraq. This technique allows better exposure during intubation while limiting mouth opening and cervical hyper extension, but also dental trauma and lip wounds. It also reduces the duration of laryngoscopy and therefore at the same time the apnea time. After a review of the literature, it has been proven that its use reduces haemodynamic changes during intubation. But these studies have been realized only in very particular patients (obese, heart failure) and with induction protocols that are not used routinely in our operating theaters.

Reasons why it decided to carry out this study, on the one hand to find these results and especially to be able to extend them to the whole population.

Conditions

Orotracheal Intubation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

orotracheal intubation direct

Group Type: OTHER

orotracheal intubation by direct laryngoscopy

Intervention Type: DEVICE

Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch

orotracheal intubation indirect

Group Type: OTHER

orotracheal intubation by indirect laryngoscopy

Intervention Type: DEVICE

orotracheal intubation by indirect laryngoscopy by Airtraq

Interventions

orotracheal intubation by direct laryngoscopy

Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch

Intervention Type: DEVICE

orotracheal intubation by indirect laryngoscopy

orotracheal intubation by indirect laryngoscopy by Airtraq

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Specific medical conditions: ASA 1 or 2
• Patient having given written consent to participate in the category 2 trial
• Intubation realized by experienced person
• Social Insured Patient
• Patient willing to comply with all procedures of the study and its duration

Exclusion Criteria

• Demographic characteristics: minor, over 65
• Medical history: history of difficult intubation, hypertension
• Lille intubation score greater than or equal to 7
• Treatments in progress: Beta taking blocking the day of the operation.
• Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vygon GmbH & Co. KG

INDUSTRY

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elsa Jozefowicz, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Roger Salengro, CHU

Lille, , France

Countries

France

Other Identifiers

2018-A01683-52

Identifier Type: OTHER

Identifier Source: secondary_id

2017_72

Identifier Type: -

Identifier Source: org_study_id