Anesthesia GeneralD-VelocityNCT02930096
Study of the Effect of the Supine Position at Brain Velocities in Noncerebro - Injured Patient
An observational study of Anesthesia General, run by Poitiers University Hospital at 1 site in France.
Trial summary
To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anesthesia General
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Mar 2018
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient who need a surgery in supine position and who don't have brain injured or pulmonary desease. Forty patients over 24 month period were included in the study, after informed consent. Pulsatility index is mesured with doppler ultrasound: 1. before general anesthesia 2. after general anesthesia in dorsal position 3. in supine position 4. in supine position with 15° proclive Evaluation to the pulsatility index changes in theese position
Who may be able to join
- minimum 18 years old, maximum 45 years old for men and 55 years old for women.
- surgery with supine position.
Who cannot join
- refusal to participate
- failure of measurement brain velocity
- Penthotal or de kétamine before measurment
- Cardiac or pulmonary desease
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia.
- Conditions
- Anesthesia General
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pulsatility index mesured with doppler ultrasound | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the pulsatility index after setting prone position in non brain-injured patient
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia GeneralStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930096
- Sponsor's protocol ID
- D-Velocity
- Acronym
- D-Velocity
- Status last verified
- Apr 2020
- First submitted
- 4 Oct 2016
- Last updated
- 13 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of the Supine Position at Brain Velocities in Noncerebro - Injured Patient
- ClinicalTrials.gov ID
- NCT02930096
- Acronym / sponsor ID
- D-Velocity / D-Velocity
- Conditions
- Anesthesia General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018
- First posted
- 12 Oct 2016 (estimated)
- 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.
To evaluate the pulsatility index changes after setting supine position in non brain- injured patient under general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pulsatility index mesured with doppler ultrasound | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient who need a surgery in supine position and who don't have brain injured or pulmonary desease. Forty patients over 24 month period were included in the study, after informed consent. Pulsatility index is mesured with doppler ultrasound: 1. before general anesthesia 2. after general anesthesia in dorsal position 3. in supine position 4. in supine position with 15° proclive Evaluation to the pulsatility index changes in theese position
Key inclusion criteria (2 listed)
- minimum 18 years old, maximum 45 years old for men and 55 years old for women.
- surgery with supine position.
Key exclusion criteria (4 listed)
- refusal to participate
- failure of measurement brain velocity
- Penthotal or de kétamine before measurment
- Cardiac or pulmonary desease
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
Evaluation the pulsatility index after setting prone position in non brain-injured patient
Time frame: 10 minutes
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 13 Apr 2020.
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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 Anesthesia General, run by Poitiers University Hospital 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 2 inclusion and 4 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 13 Apr 2020. 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?
Evaluation the pulsatility index after setting prone position in non brain-injured patient (time frame: 10 minutes). 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 13 Apr 2020.