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

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Intubation; Deep Sedation

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients who were sedated by isoflurane with Anesthetic-conserving device in pre-hospital by the emergency teams of SAMU 29

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 3, 2019
• Primary Completion (ACTUAL): June 3, 2019
• Study Completion (ACTUAL): June 3, 2019

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: ANACONDA (29BRC19.0016)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie result in a publication
• IPD Sharing Time Frame: Data will be available beginning three months and ending five years following the publication
• IPD Sharing Access Criteria: Data access requests will be rewiewed by internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No