Clinical trial NCT03743831: Comparison of Haemodynamic Effects During Orotracheal Intubation, by Direct or Indirect Laryngoscopy With Airtraq
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orotracheal Intubation
Keywords: Laryngoscopy direct
Laryngoscopy indirect by Airtraq
hemodynamic changes
side effects
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Vygon GmbH & Co. KG
First posted: 2018-11-16
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: change from intubation mean blood pressure at 1 min after intubation
timeFrame: between the values before intubation (T0) and 1min after intubation.
Secondary outcomes:
measure: Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20%
timeFrame: between values before intubation and 1, 2, 5, 10 minutes after intubation.
measure: Variation of blood pressure (PAM)
timeFrame: between the values before intubation (T0) and 2, 5 and 10 minutes of intubation
measure: Variation of heart rate (HR)
timeFrame: between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation
measure: Mean of the arterial blood pressure and heart rate
timeFrame: before intubation and at 1,2,5 and 10 minutes from intubation.
measure: Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon
timeFrame: at 1 min after intubation
measure: Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device.
timeFrame: at 10 min after intubation
measure: instantaneous ANI delta
timeFrame: between ANI before intubation and 1,2,5 and 10 min after intubation
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Elsa Jozefowicz, MD
role: PRINCIPAL_INVESTIGATOR
References: