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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02513511
Other study ID # 169/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2015
Est. completion date September 25, 2019

Study information

Verified date September 2019
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Awake intubation is a recommended safety procedure in specific cases where the intubation or ventilation before general anesthesia is at risk.

Numerous techniques to allow awake intubation have been described, such as pure awake technique, local anesthetics or intravenous sedation for example.

Hypnosis is used for various operating room techniques and surgeries. The investigators aim to analyze the feasibility of awake laryngoscopy and intubations on patients placed under hypnosis alone.


Description:

Awake intubation is a recommended safety procedure in specific cases where the intubation or ventilation before general anesthesia is at risk.

Numerous techniques to allow awake intubation have been described, such as pure awake technique, local anesthetics or intravenous sedation for example.

Hypnosis is used for various operating room techniques and surgeries. The investigators aim to analyze the feasibility of awake laryngoscopy and intubations on patients placed under hypnosis alone.

Once patient will consent to be enrolled in the study, the same physician, trained in hypnosis, will accompany the patient in the operating room and place him into a hypnotic state. Once this hypnotic state is achieved, an oro-tracheal laryngoscopy will be performed with an Airtraq videolaryngoscope by an experienced anesthetist, specialised in the management of the difficult airway. If conditions allow it, the laryngoscopy will be followed by an oro-tracheal intubation.

A questionnaire assessing objective and subjective criteria from the patient and from the airway specialist will be collected.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 25, 2019
Est. primary completion date September 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults

- american society of anesthesiology classification 1-3

- understanding of french language

Exclusion Criteria:

- history of difficult intubation

- patient refusal

- deafness

- uncomfortable with french language understanding

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
laryngoscopy under hypnosis
patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation

Locations

Country Name City State
Switzerland Dpt of Anesthesiology, University of Lausanne CHUV Lausanne VD

Sponsors (1)

Lead Sponsor Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants in which laryngoscopy is possible under hypnosis laryngoscopy is feasible under hypnosis alone 60 minutes
Secondary Number of participants in which intubation is possible under hypnosis intubation is feasible under hypnosis alone 60 minutes
Secondary comfort assessed by patient assessment of comfort on scale 1-5 60 minutes
Secondary comfort assessed by doctor assessment of comfort on scale 1-5 60 minutes
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