Hypnosis to Perform Awake Intubation (Hypnotube)

September 25, 2019 updated by: Patrick Schoettker,MD PD, University of Lausanne Hospitals

Hypnosis as a Sole Agent to Perform Awake Intubation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Dpt of Anesthesiology, University of Lausanne CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypnosis
the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation.
Procedure: laryngoscopy under hypnosis
patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in which laryngoscopy is possible under hypnosis
Time Frame: 60 minutes
laryngoscopy is feasible under hypnosis alone
60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in which intubation is possible under hypnosis
Time Frame: 60 minutes
intubation is feasible under hypnosis alone
60 minutes
comfort assessed by patient
Time Frame: 60 minutes
assessment of comfort on scale 1-5
60 minutes
comfort assessed by doctor
Time Frame: 60 minutes
assessment of comfort on scale 1-5
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 25, 2019

Study Completion (Actual)

September 25, 2019

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 169/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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