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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Orotracheal Intubation

Intervention / Treatment
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* Device: orotracheal intubation by direct laryngoscopy
* Device: orotracheal intubation by indirect laryngoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: orotracheal intubation direct<br> | Device: orotracheal intubation by direct laryngoscopy<br>* Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch<br>|
| Other: orotracheal intubation indirect<br> | Device: orotracheal intubation by indirect laryngoscopy<br>* orotracheal intubation by indirect laryngoscopy by Airtraq<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngoscopy direct, Laryngoscopy indirect by Airtraq, hemodynamic changes, side effects