Cardiac SurgeryNCT02145585
Robotic Pharmacological Anesthesia System for Elective Cardiac Surgery
An observational study of Cardiac Surgery, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Test of pharmacologic anesthesia robot (labVIEW® software)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to May 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiac surgery with extracorporeal circulation
Who may be able to join
- Elective patients
- Patients scheduled to receive an extracorporeal circulation
- Patients aged 18 and older
Who cannot join
- Minor
- Unable to provide informed consent
- Comatose patients
- Patients with dementia
- Patient who underwent neurosurgery
- Pregnant women
- Patient with muscle disease
- Allergy to Propofol and/or remifentanil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study
Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe and is more efficient than manual administration of anaesthetic drugs. Although the results of this study are very encouraging, they are limited by its sample of patients recruited for non-cardiac surgery only.
The hypothesis of the present trial is that cardiac anesthesia using a completely automated anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia and muscle relaxation) is feasible, safe and reliable.
Read more
Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.
Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).
A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).
- Conditions
- Cardiac Surgery
- Being tested
- Test of pharmacologic anesthesia robot (labVIEW® software)
- Keywords
- Cardiac surgery, Robotic pharmacological anesthesia, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of pharmacologic anesthesia robot (labVIEW® software)Device
| Study group | Role | What they receive |
|---|---|---|
| Robotic pharmacological system | Robotic pharmacological system/Automated anesthesia delivery system Receives: Device: Test of pharmacologic anesthesia robot (labVIEW® software) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.
Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).
Measured: at inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cédrick ZAOUTER, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145585
- Sponsor's protocol ID
- CHUBX RNI 01/2014
- Status last verified
- Dec 2014
- First submitted
- 14 May 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Completely Automated Robotic Pharmacological Anesthesia System for Patients Undergoing Elective Cardiac Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT02145585
- Acronym / sponsor ID
- CHUBX RNI 01/2014
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac surgery, Robotic pharmacological anesthesia, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 May 2014 (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.
Closed loop systems for anaesthesia have been shown to be more efficient than manual administration and than Target Control Infusion systems (TCI). So far, there is only one single-center study demonstrating that a system using simultaneously three closed loops for each component of anaesthesia (hypnosis, analgesia and muscle relaxation) is possible, safe and is more efficient than manual administration of anaesthetic drugs. Although the results of this study are very encouraging, they are limited by its sample of patients recruited for non-cardiac surgery only.
The hypothesis of the present trial is that cardiac anesthesia using a completely automated anesthesia delivery system, encompassing each components of anesthesia (hypnosis, analgesia and muscle relaxation) is feasible, safe and reliable.
Thus, the objective of the present trial is to test this pharmacologic anesthesia robot on patients scheduled for elective cardiac surgical procedures with extracorporeal circulation.
Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).
A BIS target of 45 is aimed trough the surgery. Performance of propofol hypnosis will be determined clinically by recording the % of sedation time during which the actual BIS is within 10% of the target BIS (excellent control), within 11 -20% (good control), between 21-30% (fair control) and beyond 30% of target (inadequate control).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic pharmacological system | – | Device: Test of pharmacologic anesthesia robot (labVIEW® software)Robotic pharmacological system/Automated anesthesia delivery system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiac surgery with extracorporeal circulation
Key inclusion criteria (3 listed)
- Elective patients
- Patients scheduled to receive an extracorporeal circulation
- Patients aged 18 and older
Key exclusion criteria (8 listed)
- Minor
- Unable to provide informed consent
- Comatose patients
- Patients with dementia
- Patient who underwent neurosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of pharmacologic anesthesia robot (labVIEW® software) | Device | Robotic pharmacological system |
Primary outcome
Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible.
Time frame: at inclusion (day 0)
Hypnosis is monitored during the surgery according to the brain activity values provided by an objective monitoring parameter, called Bispectral Index (BIS).
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 18 Dec 2014.
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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.
Cédrick ZAOUTER, MD principal investigator
University Hospital, Bordeaux
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 Cardiac Surgery, run by University Hospital, Bordeaux 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 8 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 18 Dec 2014. 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?
Performance of closed-loop system for propofol administration defined as the efficacy to maintain Bispectral Index (BIS) as close to the target of 45 as possible. (time frame: at inclusion (day 0)). 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 18 Dec 2014.