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OpenTrials
Completed

NCT Number: NCT03539185

Airtraq Versus Fiberoptic for Awake Tracheal Intubation

The airway management is a vital act in anesthesia. The gold standard technique for planned very difficult intubation is nasotracheal fiberoptic intubation. The success rate with this procedure is 98.8%. However, learning this technique is difficult and it's considered uncomfortable by patients and practitioners.

The Airtraq® videolaryngoscope is commonly used for difficult orotracheal intubation. Cases of awake intubation by Airtraq® have been described.

Furthermore, the French Society of Anesthesia-Resuscitation, in its last formalized expert recommendations (2017) on difficult intubation, proposes the use of video laryngoscopes as an alternative to the fiberoptic bronchoscope.

We propose a non-inferiority study evaluating the use of Airtraq® for the realization of a awake intubation compared to the gold standard (fiberoptic bronchoscope). This prospective randomized study should include 78 patients in two groups. The purpose of this study is to improve the comfort of patient and practitioner during an awake tracheal intubation, to facilitate the learning of the technique.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen

Caen, Normandy, 14000, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Formal indication of awake intubation or patient with two criteria of difficult intubation and ventilation
  • Major patient
  • Patient able to understand oral and written information

Exclusion criteria

  • Mouth opening (inter-incisor distance) <16 mm does not allow insertion of the Airtraq® videolaryngoscope
  • Surgery requires nasotracheal intubation
  • Loco-regional anesthesia of larynx impossible

Treatment and study plan

Videolaryngoscope Airtraq

Device

Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation

Fiberoptic bronchoscope

Device

Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation

Primary outcomes

  1. Success of orotracheal or nasotracheal intubation.

    Time frame: 1 day

    Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram

Secondary outcomes

  1. Length of the proceedings

    Time frame: 1 day

    Duration between the insertion of device and the appearance of capnogram

  2. Rate of occurrence of adverse events

    Time frame: 1 day

    Coughing, desaturation, agitation

  3. Patient satisfaction score

    Time frame: 1 day

    Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction.

  4. Operator satisfaction score

    Time frame: 1 day

    Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction.

  5. Number of intubation attempts

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 29, 2018
Registry last updated
Oct 19, 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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