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

Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq, Controlled, Prospective, Randomized, Simple-blind, Monocentric Study at the Lille University Hospital Specialties Block.

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.

Study Overview

• Status: Completed
• Conditions: Orotracheal Intubation
• Intervention / Treatment: Device: orotracheal intubation by direct laryngoscopy; Device: orotracheal intubation by indirect laryngoscopy

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: orotracheal intubation direct	Device: orotracheal intubation by direct laryngoscopy; Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch
OTHER: orotracheal intubation indirect	Device: orotracheal intubation by indirect laryngoscopy; orotracheal intubation by indirect laryngoscopy by Airtraq

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from intubation mean blood pressure at 1 min after intubation	between the values before intubation (T0) and 1min after intubation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%		between values before intubation and 1, 2, 5, 10 minutes after intubation.
Variation of blood pressure (PAM)		between the values before intubation (T0) and 2, 5 and 10 minutes of intubation
Variation of heart rate (HR)		between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation
Mean of the arterial blood pressure and heart rate	delta defined by the difference between the values	before intubation and at 1,2,5 and 10 minutes from intubation.
Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon		at 1 min after intubation
Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.		at 10 min after intubation
instantaneous ANI delta		between ANI before intubation and 1,2,5 and 10 min after intubation

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Vygon GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2018
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (ACTUAL): November 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: side effects; Laryngoscopy direct; Laryngoscopy indirect by Airtraq; hemodynamic changes
• Other Study ID Numbers: 2017_72; 2018-A01683-52 (OTHER: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No