Endotracheal IntubationANACONDANCT04141267
Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.
An observational study of Endotracheal Intubation and Deep Sedation, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Deep Sedation
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2019to 3 Jun 2019
- Phase
- Observational
- 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
Study population: patients who were sedated by isoflurane with Anesthetic-conserving device in pre-hospital by the emergency teams of SAMU 29
Who may be able to join
- Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital
- Major patient
- not opposed to participating
Who cannot join
- Adults Under legal protection
- patient refusal to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.
- Conditions
- Endotracheal Intubation, Deep Sedation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 1 day
Secondary outcomes (2)
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
Measured: 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
Measured: up to 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start3 May 2019
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141267
- Sponsor's protocol ID
- ANACONDA (29BRC19.0016)
- Acronym
- ANACONDA
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie result in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Isoflurane Sedation Using an Anesthetic-conserving Device in Prehospital Emergency Medicine: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04141267
- Acronym / sponsor ID
- ANACONDA / ANACONDA (29BRC19.0016)
- Conditions
- Endotracheal Intubation, Deep Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 28 Oct 2019 (actual)
- 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.
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.
Detailed description
Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were sedated by isoflurane with Anesthetic-conserving device in pre-hospital by the emergency teams of SAMU 29
Key inclusion criteria (3 listed)
- Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital
- Major patient
- not opposed to participating
Key exclusion criteria (2 listed)
- Adults Under legal protection
- patient refusal to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
depth of sedation
Time frame: up to 1 day
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).
2 secondary outcomes
hemodynamic tolerance of patients during isoflurane sedation
Time frame: up to 1 day
hemodynamic tolerance of patients during isoflurane sedation
Time frame: up to 1day
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 28 Oct 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie result in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endotracheal Intubation and Deep Sedation, run by University Hospital, Brest at 1 site in France.
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 2 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 28 Oct 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 France. 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?
depth of sedation (time frame: up to 1 day). 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 28 Oct 2019.