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NCT04141267 Clinical Trial

Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.

Endotracheal Intubation Clinical Trial

— ANACONDA  

Official title:
Feasibility of Isoflurane Sedation Using an Anesthetic-conserving Device in Prehospital Emergency Medicine: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04141267
Other study ID # ANACONDA (29BRC19.0016)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2019
Est. completion date June 3, 2019

Study information
Verified date February 2019
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Achieving the optimal sedation level for patient management is not always possible using our standard intravenous medications in Pre-hospital Emergency medicine. Inhaled sedation is possible with the Anesthetic-conserving device with a standard respirator.

The pharmacodynamics and pharmacokinetics of halogenated agents allow deep sedation quickly after absorption.

The feasibility of inhaled sedation has never been studied in hospital.

Description:

Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 3, 2019
Est. primary completion date June 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital

- Major patient

- not opposed to participating

Exclusion Criteria:

- Adults Under legal protection

- patient refusal to participate in study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary depth of sedation depth of sedation (measured by the Ramsay Score) 10 minutes from start of the sedation and at stop of pre hospital sedation. The Ramsay score ranges level of sedation from 1(patient anxious ,agitated,restless) to 6 (patient exhibits no response). up to 1 day
Secondary hemodynamic tolerance of patients during isoflurane sedation comparison of heart rate (heart beats per minute) before isoflurane start and 10 minutes from start of the sedation and at stop of pre hospital sedation up to 1 day
Secondary hemodynamic tolerance of patients during isoflurane sedation comparison of medium blood pressure (mmHg) before isoflurane start and 10 minutes from start of the sedation and at stop of pre hospital sedation up to 1day
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