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Completed

NCT Number: NCT03743831

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

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.

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Key information

Conditions

Orotracheal Intubation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

orotracheal intubation by direct laryngoscopy

Device

Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch

orotracheal intubation by indirect laryngoscopy

Device

orotracheal intubation by indirect laryngoscopy by Airtraq

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Vygon GmbH & Co. KG

Registry information

Official study 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.

Acronym: HEMODAIRTRAQ

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 16, 2018
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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