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

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ClinicalTrials.gov Identifier: NCT03743831
Recruitment Status : Completed
First Posted : November 16, 2018
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
Vygon GmbH & Co. KG
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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.


Condition or disease Intervention/treatment Phase
Orotracheal Intubation Device: orotracheal intubation by direct laryngoscopy Device: orotracheal intubation by indirect laryngoscopy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : December 4, 2018
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019
Arms and Interventions
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Arm Intervention/treatment
orotracheal intubation direct Device: orotracheal intubation by direct laryngoscopy
Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch
orotracheal intubation indirect Device: orotracheal intubation by indirect laryngoscopy
orotracheal intubation by indirect laryngoscopy by Airtraq


Outcome Measures
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Primary Outcome Measures :
  1. change from intubation mean blood pressure at 1 min after intubation [ Time Frame: between the values before intubation (T0) and 1min after intubation. ]

Secondary Outcome Measures :
  1. Frequency of patients with hemodynamic reaction post intubation (minimal variation of mean blood pressure or heart rate of 20% [ Time Frame: between values before intubation and 1, 2, 5, 10 minutes after intubation. ]
  2. Variation of blood pressure (PAM) [ Time Frame: between the values before intubation (T0) and 2, 5 and 10 minutes of intubation ]
  3. Variation of heart rate (HR) [ Time Frame: between the values before intubation (T0) and 1, 2, 5 and 10 minutes of intubation ]
  4. Mean of the arterial blood pressure and heart rate [ Time Frame: before intubation and at 1,2,5 and 10 minutes from intubation. ]
    delta defined by the difference between the values

  5. Intubation time in seconds from introduction of the intubation device into the mouth with inflation of the balloon [ Time Frame: at 1 min after intubation ]
  6. Frequency of patients with dental trauma and / or an injury to the lips due to the intubation device. [ Time Frame: at 10 min after intubation ]
  7. instantaneous ANI delta [ Time Frame: between ANI before intubation and 1,2,5 and 10 min after intubation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743831


Locations
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France
Hôpital Roger Salengro, CHU
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Vygon GmbH & Co. KG
Investigators
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Principal Investigator: Elsa Jozefowicz, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03743831    
Other Study ID Numbers: 2017_72
2018-A01683-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Laryngoscopy direct
Laryngoscopy indirect by Airtraq
hemodynamic changes
side effects