Hypnosis to Perform Awake Intubation (Hypnotube)
Primary Purpose
Nasal Obstruction
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
laryngoscopy under hypnosis
Sponsored by
About this trial
This is an interventional supportive care trial for Nasal Obstruction focused on measuring difficult airway, awake intubation
Eligibility Criteria
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
Sites / Locations
- Dpt of Anesthesiology, University of Lausanne CHUV
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypnosis
Arm Description
the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation.
Outcomes
Primary Outcome Measures
Number of participants in which laryngoscopy is possible under hypnosis
laryngoscopy is feasible under hypnosis alone
Secondary Outcome Measures
Number of participants in which intubation is possible under hypnosis
intubation is feasible under hypnosis alone
comfort assessed by patient
assessment of comfort on scale 1-5
comfort assessed by doctor
assessment of comfort on scale 1-5
Full Information
NCT ID
NCT02513511
First Posted
July 28, 2015
Last Updated
September 25, 2019
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT02513511
Brief Title
Hypnosis to Perform Awake Intubation
Acronym
Hypnotube
Official Title
Hypnosis as a Sole Agent to Perform Awake Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
Keywords
difficult airway, awake intubation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis
Arm Type
Experimental
Arm Description
the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation.
Intervention Type
Procedure
Intervention Name(s)
laryngoscopy under hypnosis
Intervention Description
patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation
Primary Outcome Measure Information:
Title
Number of participants in which laryngoscopy is possible under hypnosis
Description
laryngoscopy is feasible under hypnosis alone
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Number of participants in which intubation is possible under hypnosis
Description
intubation is feasible under hypnosis alone
Time Frame
60 minutes
Title
comfort assessed by patient
Description
assessment of comfort on scale 1-5
Time Frame
60 minutes
Title
comfort assessed by doctor
Description
assessment of comfort on scale 1-5
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
patrick Schoettker, MD, PD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Anesthesiology, University of Lausanne CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
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Hypnosis to Perform Awake Intubation
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