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

Not Applicable

Completed

• Conditions: Orotracheal Intubation
• Interventions: Device: orotracheal intubation by direct laryngoscopy; Device: orotracheal intubation by indirect laryngoscopy

• Registration Number: NCT03743831
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2018-12-04
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
orotracheal intubation direct	orotracheal intubation by direct laryngoscopy	-
orotracheal intubation indirect	orotracheal intubation by indirect laryngoscopy	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.	at 10 min after 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	before intubation and at 1,2,5 and 10 minutes from intubation.	delta defined by the difference between the values
instantaneous ANI delta	between ANI before intubation and 1,2,5 and 10 min after intubation
Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon	at 1 min after intubation

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU; 🇫🇷 Lille, France