- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02513511
Hypnosis to Perform Awake Intubation (Hypnotube)
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
VD
-
Lausanne, VD, Schweiz, 1011
- Dpt of Anesthesiology, University of Lausanne CHUV
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Hypnosis
the investigators will put the patient into a hypnotic state and analyze laryngoscopy under hypnosis, followed by intubation.
|
patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants in which laryngoscopy is possible under hypnosis
Tidsramme: 60 minutes
|
laryngoscopy is feasible under hypnosis alone
|
60 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants in which intubation is possible under hypnosis
Tidsramme: 60 minutes
|
intubation is feasible under hypnosis alone
|
60 minutes
|
|
comfort assessed by patient
Tidsramme: 60 minutes
|
assessment of comfort on scale 1-5
|
60 minutes
|
|
comfort assessed by doctor
Tidsramme: 60 minutes
|
assessment of comfort on scale 1-5
|
60 minutes
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 169/14
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