Nasal ObstructionHypnotubeNCT02513511
Hypnosis to Perform Awake Intubation
A study testing laryngoscopy under hypnosis in people with Nasal Obstruction, run by University of Lausanne Hospitals at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- laryngoscopy under hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2015to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults
- american society of anesthesiology classification 1-3
- understanding of french language
Who cannot join
- history of difficult intubation
- patient refusal
- deafness
- uncomfortable with french language understanding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dpt of Anesthesiology, University of Lausanne CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Obstruction
- Being tested
- laryngoscopy under hypnosis
- Keywords
- difficult airway, awake intubation
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscopy under hypnosisProcedure or surgery
patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation. Receives: Procedure: laryngoscopy under hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in which laryngoscopy is possible under hypnosis
laryngoscopy is feasible under hypnosis alone
Measured: 60 minutes
Secondary outcomes (3)
Number of participants in which intubation is possible under hypnosis
intubation is feasible under hypnosis alone
Measured: 60 minutes
comfort assessed by patient
assessment of comfort on scale 1-5
Measured: 60 minutes
comfort assessed by doctor
assessment of comfort on scale 1-5
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study start1 Aug 2015
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker,MD PD, University of Lausanne Hospitals
- Investigators
- patrick Schoettker, MD, PD, Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513511
- Sponsor's protocol ID
- 169/14
- Acronym
- Hypnotube
- Status last verified
- Sep 2019
- First submitted
- 28 Jul 2015
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis as a Sole Agent to Perform Awake Intubation
- ClinicalTrials.gov ID
- NCT02513511
- Acronym / sponsor ID
- Hypnotube / 169/14
- Conditions
- Nasal Obstruction
- Keywords
- difficult airway, awake intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 31 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Procedure: laryngoscopy under hypnosisthe investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults
- american society of anesthesiology classification 1-3
- understanding of french language
Key exclusion criteria (4 listed)
- history of difficult intubation
- patient refusal
- deafness
- uncomfortable with french language understanding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laryngoscopy under hypnosispatient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation | Procedure or surgery | Hypnosis |
Primary outcome
Number of participants in which laryngoscopy is possible under hypnosis
Time frame: 60 minutes
laryngoscopy is feasible under hypnosis alone
3 secondary outcomes
Number of participants in which intubation is possible under hypnosis
Time frame: 60 minutes
comfort assessed by patient
Time frame: 60 minutes
comfort assessed by doctor
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
patrick Schoettker, MD, PD principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngoscopy under hypnosis in people with Nasal Obstruction, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in which laryngoscopy is possible under hypnosis (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.