Hypnosis to Perform Awake Intubation | NCT02513511

Studies
Hypnosis to Perform Awake Intubation

NCT02513511

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Sep 27, 2019Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Nasal Obstruction

Interventions

laryngoscopy under hypnosis

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2015Actual

Primary Completion Date

Sep 25, 2019Actual

Completion Date

Sep 25, 2019Actual

First Submitted Date

Jul 28, 2015

First Submission Date that Met QC Criteria

Jul 29, 2015

First Posted Date

Jul 31, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schoettker,MD PD, MD, PD, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypnosis	Experimental	the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation.	Procedure: laryngoscopy under hypnosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laryngoscopy under hypnosis	Procedure	patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation	Hypnosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
patrick Schoettker, MD, PD	University of Lausanne Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt of Anesthesiology, University of Lausanne CHUV		Lausanne	Canton of Vaud	1011	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D015508	Nasal Obstruction

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency

Browse Leaves

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Browse Branches

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