Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Airtraq Versus Fiberoptic for Awake Tracheal Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539185
Recruitment Status : Completed
First Posted : May 29, 2018
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Intubation;Difficult Awake Intubation Airway Complication of Anesthesia Device: Videolaryngoscope Airtraq Device: Fiberoptic bronchoscope Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority trial. Alpha risk de 2,5%, Power 90 %
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Airtraq Versus Fiberoptic for Awake Tracheal Intubation : A Randomised Non-inferiority Trial
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : May 18, 2020
Actual Study Completion Date : May 18, 2020

Arm Intervention/treatment
Active Comparator: Airtraq
Awake tracheal intubation using airtraq videolaryngoscope.
Device: Videolaryngoscope Airtraq
Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation

Active Comparator: Fiberoptic
Awake nasotracheal tracheal intubation using flexible fiberoptic bronchoscope.
Device: Fiberoptic bronchoscope
Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03539185


Locations
Layout table for location information
France
CHU de Caen
Caen, Normandie, France, 14000
Sponsors and Collaborators
University Hospital, Caen
Investigators
Layout table for investigator information
Principal Investigator: Alexandre FRUGIER, Résident University Hospital, Caen
Principal Investigator: Hervé KAMGA, Dr University Hospital, Caen
Publications of Results:

Layout table for additonal information
Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03539185    
Other Study ID Numbers: 2018-A00239-46
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
Airtraq
Fiberoptic
Awake
Tracheal intubation
laryngeal nerve blocks
sedation
remifentanil