Valve Heart DiseaseNCT04958668
Prospective Evaluation of Volatile Sedation After Heart Valve Surgery
A study testing Post-operative intensive care using volatile sedation in people with Valve Heart Disease and Awakening Early, run by Goethe University at 1 site in Germany.
Trial summary
Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valve Heart Disease, Awakening Early
- What is being tested?
- Post-operative intensive care using volatile sedation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to 1 Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- Valve reconstruction or valve replacement
- Must be capable to giving written consent
Who cannot join
- Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)
- Severe obstructive pulmonary disease
- Extended aortic arch or ascending aorta surgery
- Age <18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery
Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.
The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.
- Conditions
- Valve Heart Disease, Awakening Early
- Being tested
- Post-operative intensive care using volatile sedation
- Medical subject headings
- Heart Valve Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative intensive care using volatile sedationOther
Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..
| Study group | Role | What they receive |
|---|---|---|
| Volatile procedere | Active comparator | Intensive care treatment with demand-adapted sedation with volatile anaesthetics Receives: Other: Post-operative intensive care using volatile sedation |
| Conventional procedere | No intervention | Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation
Time from admission on ICU until awakening and Extubation.
Measured: through study completion, an average of 2 days
Secondary outcomes (11)
Time to neurocognitive assessability
Time from admission on ICU until awake and neurocognitive assessable.
Measured: through study completion, an average of 2 days
Required setup time of the intensive care workplace
Required setup time of the intensive care workplace to provide volatile or intravenous sedation.
Measured: through study completion, up to 24 hours
Factor related to the course of intensive care: blood loss
Measured Postoperative Blood Loss
Measured: through study completion, an average of 24 hours
Factor related to the course of intensive care: kidney injury
Measured increases in serum renal retention levels: creatinine and urea in terms of renal failure according to Kidney Disease - Improving Global Outcomes (KDIGO) criteria.
Measured: through study completion, an average of 24 hours
Factor related to the course of intensive care: acid-base balance
Measured serum lactate levels and hypercapnia
Measured: through study completion, an average of 24 hours
Factor related to the course of intensive care: lung function parameters
Required inspiratory oxygen fraction
Measured: through study completion, an average of 24 hours
Factor related to the course of intensive care:cardiovascular medication
Required dosage of adrenaline, noradrenaline, vasopressin or milrinone
Measured: through study completion, an average of 24 hours
Factors related to the course of operative procedure
time of the intraoperative procedure including the heart-lung-machine
Measured: through study completion, up to 24 hours
Intra-hospital mortality
Intra-hospital mortality - Safety outcome
Measured: through study completion, an average of 7 days
Liver failure
Intra-hospital liver failure - Safety outcome
Measured: through study completion, an average of 7 days
postoperative nausea and vomiting
Detection of postoperative nausea and vomiting
Measured: through study completion, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Nov 2021
- Primary completion28 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
- Investigators
- Armin N Flinspach, M.D., Principal investigator, JWGoethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958668
- Sponsor's protocol ID
- 20-1050
- Status last verified
- Jan 2024
- First submitted
- 28 Jun 2021
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flinspach AN, Raimann FJ, Kaiser P, Pfaff M, Zacharowski K, Neef V, Adam EH. Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial. Crit Care. 2024 Apr 5;28(1):111. doi: 10.1186/s13054-024-04899-y.
PubMed 38581030Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804.
PubMed 35197356
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Volatile Sedation With Regard to Awakening Behaviour and Extubation Capacity in Patients Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT04958668
- Acronym / sponsor ID
- 20-1050
- Conditions
- Valve Heart Disease, Awakening Early
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 12 Jul 2021 (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.
Cardiac surgery is a complex operative procedure with a substantial risk of postoperative complications, so that patients undergoing valve surgery are usually transferred to the intensive care unit postoperatively. Various substances are used to maintain the required sedation, such as volatile anaesthetics and intravenous sedatives combined with analgetic therapy using opioids.
The study intends to investigate to what extent the already well-described effect of volatile anaesthetics on recovery can be realised despite the need for differentiated intensive care and medical management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volatile procedere | Active comparator | Other: Post-operative intensive care using volatile sedationIntensive care treatment with demand-adapted sedation with volatile anaesthetics |
| Conventional procedere | No intervention | –Conventional Intensive care treatment with demand-adapted sedation with intravenous sedatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Valve reconstruction or valve replacement
- Must be capable to giving written consent
Key exclusion criteria (4 listed)
- Intolerance to volatile anaesthetics (e.g. malignant hyperthermia)
- Severe obstructive pulmonary disease
- Extended aortic arch or ascending aorta surgery
- Age <18 years
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 |
|---|---|---|
| Post-operative intensive care using volatile sedationPatients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management.. | Other | Volatile procedere |
Primary outcome
Time to extubation
Time frame: through study completion, an average of 2 days
Time from admission on ICU until awakening and Extubation.
11 secondary outcomes
Time to neurocognitive assessability
Time frame: through study completion, an average of 2 days
Required setup time of the intensive care workplace
Time frame: through study completion, up to 24 hours
Factor related to the course of intensive care: blood loss
Time frame: through study completion, an average of 24 hours
Factor related to the course of intensive care: kidney injury
Time frame: through study completion, an average of 24 hours
Factor related to the course of intensive care: acid-base balance
Time frame: through study completion, an average of 24 hours
Factor related to the course of intensive care: lung function parameters
Time frame: through study completion, an average of 24 hours
Factor related to the course of intensive care:cardiovascular medication
Time frame: through study completion, an average of 24 hours
Factors related to the course of operative procedure
Time frame: through study completion, up to 24 hours
Intra-hospital mortality
Time frame: through study completion, an average of 7 days
Liver failure
Time frame: through study completion, an average of 7 days
postoperative nausea and vomiting
Time frame: through study completion, up to 24 hours
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 9 Jan 2024.
- Derived from this study: PubMed 38581030Flinspach AN, Raimann FJ, Kaiser P, Pfaff M, Zacharowski K, Neef V, Adam EH. Volatile versus propofol sedation after cardiac valve surgery: a single-center prospective randomized controlled trial. Crit Care. 2024 Apr 5;28(1):111. doi: 10.1186/s13054-024-04899-y.
- Derived from this study: PubMed 35197356Flinspach AN, Herrmann E, Raimann FJ, Zacharowski K, Adam EH. Evaluation of volatile sedation in the postoperative intensive care of patients recovering from heart valve surgery: protocol for a randomised, controlled, monocentre trial. BMJ Open. 2022 Feb 23;12(2):e057804. doi: 10.1136/bmjopen-2021-057804.
- Individual participant dataSharing planned: No
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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.
Armin N Flinspach, M.D. principal investigator
JWGoethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-operative intensive care using volatile sedation in people with Valve Heart Disease and Awakening Early, run by Goethe University at 1 site in Germany.
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 9 Jan 2024. 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 Germany. 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?
Time to extubation (time frame: through study completion, an average of 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04958668, which also lists 2 linked publications.
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 9 Jan 2024.