Intubation;Difficult, Awake Intubation, Airway Complication of Anesthesia
Conditions
Keywords
Airtraq, Fiberoptic, Awake, Tracheal intubation, laryngeal nerve blocks, sedation, remifentanil
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.
Interventions
DEVICEVideolaryngoscope Airtraq
Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation
DEVICEFiberoptic bronchoscope
Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Non-inferiority trial. Alpha risk de 2,5%, Power 90 %
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of orotracheal or nasotracheal intubation. | 1 day | Defined by the visualization of the tube into the trachea through vocal cords and by the appearance of the capnogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of the proceedings | 1 day | Duration between the insertion of device and the appearance of capnogram |
| Rate of occurrence of adverse events | 1 day | Coughing, desaturation, agitation |
| Patient satisfaction score | 1 day | Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction. |
| Operator satisfaction score | 1 day | Analogue visual scale graduated from zero to ten. Zero is the worst imaginable satisfaction and 10 is the better imaginable satisfaction. |
| Number of intubation attempts | 1 day | — |
Countries
France
Outcome results
None listed