NCT02513511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

July 28, 2015

Last Update Submit

September 25, 2019

Conditions

Nasal Obstruction

Keywords

difficult airwayawake intubation

Outcome Measures

Primary Outcomes (1)

  • Number of participants in which laryngoscopy is possible under hypnosis

    laryngoscopy is feasible under hypnosis alone

    60 minutes

Secondary Outcomes (3)

  • Number of participants in which intubation is possible under hypnosis

    60 minutes

  • comfort assessed by patient

    60 minutes

  • comfort assessed by doctor

    60 minutes

Study Arms (1)

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

laryngoscopy under hypnosisPROCEDURE

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

Hypnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • american society of anesthesiology classification 1-3
  • understanding of french language

You may not qualify if:

  • history of difficult intubation
  • patient refusal
  • deafness
  • uncomfortable with french language understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • patrick Schoettker, MD, PD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PD

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 31, 2015

Study Start

August 1, 2015

Primary Completion

September 25, 2019

Study Completion

September 25, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CH(1)