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

Orotracheal Intubation Clinical Trial

— HEMODAIRTRAQ  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743831
• Other study ID #: 2017_72
• Secondary ID: 2018-A01683-52
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Orotracheal Intubation

Intervention

Device:
• orotracheal intubation by direct laryngoscopy
Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch
• orotracheal intubation by indirect laryngoscopy
orotracheal intubation by indirect laryngoscopy by Airtraq

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Vygon GmbH & Co. KG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from intubation mean blood pressure at 1 min after intubation		between the values before intubation (T0) and 1min after intubation.
Secondary	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.
Secondary	Variation of blood pressure (PAM)		between the values before intubation (T0) and 2, 5 and 10 minutes of intubation
Secondary	Variation of heart rate (HR)		between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation
Secondary	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.
Secondary	Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon		at 1 min after intubation
Secondary	Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.		at 10 min after intubation
Secondary	instantaneous ANI delta		between ANI before intubation and 1,2,5 and 10 min after intubation