- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
VD
-
Lausanne, VD, Sveits, 1011
- Dpt of Anesthesiology, University of Lausanne CHUV
-
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 169/14
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