Cerebral OxygenationNCT05097170
Cerebral Oxygenation and Awareness During VT Ablation
An observational study of Cerebral Oxygenation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness. Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Oxygenation
- What is being tested?
- NIRS during ventricular tachycardia ablation
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Mar 2022
- 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 undergoing VT ablation procedure
Who may be able to join
- Patients over the age of 18
- Patients who will undergo VT ablation
- Patients who want to participate in the study
Who cannot join
- Patients whose baseline values could not be obtained before induction
- Patients with severe neurological or psychiatric illness
- Patients who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Vital Parameters on Cerebral Oxygenation and Awareness During Ventricular Tachycardia Ablation
It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness.
Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the NIRS and BIS response to blood pressure drop. In addition to the effects of patients' demographic information, cardiac capacity and procedure time on NIRS and BIS values (downtrend and duration), correlations of these values with other monitoring parameters (ETCO2 and SpO2) intended to be displayed.
- Conditions
- Cerebral Oxygenation
- Being tested
- NIRS during ventricular tachycardia ablation
- Keywords
- cerebral oxygenation, ventricular tachycardia ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS during ventricular tachycardia ablationProcedure or surgery
Also called BIS during ventricular tachycardia ablation
NIRS: Near-infrared spectroscopy is a measurement technique that non-invasively and continuously monitors the balance between cerebral oxygen consumption and delivery.
BIS: BIS is an electroencephalogram-derived parameter developed to monitor the hypnotic effects of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients under the age of 65 Receives: Procedure: NIRS during ventricular tachycardia ablation | |
| 2 | patients above the age of 65 Receives: Procedure: NIRS during ventricular tachycardia ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Infrared Spectrometer
cerebral oxygenation
Measured: perioperative (ventricular tachycardia ablation)
Secondary outcomes (1)
Bispectral Index
awareness
Measured: perioperative (ventricular tachycardia ablation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Nov 2021
- Primary completion23 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Uzumcugil, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097170
- Sponsor's protocol ID
- GO-21/704
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shivkumar K. Catheter Ablation of Ventricular Arrhythmias. N Engl J Med. 2019 Apr 18;380(16):1555-1564. doi: 10.1056/NEJMra1615244. No abstract available.
PubMed 30995375
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Vital Parameters on Cerebral Oxygenation and Awareness During Ventricular Tachycardia Ablation
- ClinicalTrials.gov ID
- NCT05097170
- Acronym / sponsor ID
- GO-21/704
- Conditions
- Cerebral Oxygenation
- Keywords
- cerebral oxygenation, ventricular tachycardia ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 Oct 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.
It is aimed to examine the effect of the decrease in blood pressure that occurs during the ventricular tachycardia ablation process on cerebral oxygenation and awareness.
Patient's age, cardiac measurements (ejection fraction-EF), basal vital values, procedure time (especially activation and pacing mapping), and localization of the arrhythmia, may affect the NIRS and BIS response to blood pressure drop. In addition to the effects of patients' demographic information, cardiac capacity and procedure time on NIRS and BIS values (downtrend and duration), correlations of these values with other monitoring parameters (ETCO2 and SpO2) intended to be displayed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: NIRS during ventricular tachycardia ablationpatients under the age of 65 |
| 2 | – | Procedure: NIRS during ventricular tachycardia ablationpatients above the age of 65 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing VT ablation procedure
Key inclusion criteria (3 listed)
- Patients over the age of 18
- Patients who will undergo VT ablation
- Patients who want to participate in the study
Key exclusion criteria (3 listed)
- Patients whose baseline values could not be obtained before induction
- Patients with severe neurological or psychiatric illness
- Patients who do not want to participate in the study
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 |
|---|---|---|
| NIRS during ventricular tachycardia ablationAlso: BIS during ventricular tachycardia ablationNIRS: Near-infrared spectroscopy is a measurement technique that non-invasively and continuously monitors the balance between cerebral oxygen consumption and delivery. BIS: BIS is an electroencephalogram-derived parameter developed to monitor the hypnotic effects of anesthesia. | Procedure or surgery | 1, 2 |
Primary outcome
Near Infrared Spectrometer
Time frame: perioperative (ventricular tachycardia ablation)
cerebral oxygenation
1 secondary outcome
Bispectral Index
Time frame: perioperative (ventricular tachycardia ablation)
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 1 Mar 2023.
- Background: PubMed 30995375Shivkumar K. Catheter Ablation of Ventricular Arrhythmias. N Engl J Med. 2019 Apr 18;380(16):1555-1564. doi: 10.1056/NEJMra1615244. No abstract available.
- 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.
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 Cerebral Oxygenation, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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 1 Mar 2023. 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 Turkey (Türkiye). 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?
Near Infrared Spectrometer (time frame: perioperative (ventricular tachycardia ablation)). 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 NCT05097170, which also lists 1 linked publication.
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 1 Mar 2023.