Blood PressureNCT05625256
Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure
An observational study of Blood Pressure, run by The Cleveland Clinic.
Trial summary
To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- SentiCor-300
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Nov 2024
- 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: Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.
Who may be able to join
- Clinical indication for arterial catheter insertion;
- Age ≥18 years;
- American Society of Anesthesiologists (ASA) physical status class ≤3;
- Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
- Planned length of surgery >60 minutes;
- Anticipated supine positioning;
- Anticipated initial recovery in the post-anesthesia care unit.
Who cannot join
- Severe peripheral vascular disease;
- Surgery that involves manipulation of large arteries
- Bypass surgery
- Positive Allen's test
- Inability to insert a catheter into an upper extremity artery;
- Patients with an arterial-venous shunt for hemodialysis;
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- Inability to measure NIBP on the arm with the arterial catheter;
- Atria l fibrillation;
- Body Mass Index (BMI) >35kg/m2;
- Esophageal or nasopharyngeal pathology, coarctation of the aorta;
- Emergency surgery.
- Surgery which involves manipulation of major arteries
About this study
Official title: Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure
To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.
Read the detailed description
Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor
Main study:
Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.
Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.
- Conditions
- Blood Pressure
- Being tested
- SentiCor-300
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentiCor-300Device
Continuous blood pressure measurement with the SentiCor-300.
| Study group | Role | What they receive |
|---|---|---|
| Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia | To compare noninvasive continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various positions. Receives: Device: SentiCor-300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.
Measured: During hospital admission
Secondary outcomes (3)
Change
Comparison of continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements during hemodynamic changes at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various postures and positions.
Measured: During hospital admission
Calibration Duration
To determine how long an oscillometric calibration of the SentiCor-300 lasts.
Measured: During hospital admission
Gender and Fitzpatrick index
To compare perform class analysis on accuracy versus gender and Fitzpatrick index.
Measured: During hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study startJun 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alparslan Turan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625256
- Sponsor's protocol ID
- 22-511
- Status last verified
- Aug 2023
- First submitted
- 6 Nov 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the SentiCor-300 Continuous Noninvasive Blood Pressure Against Invasive Arterial Blood Pressure
- ClinicalTrials.gov ID
- NCT05625256
- Acronym / sponsor ID
- 22-511
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 22 Nov 2022 (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.
To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.
Detailed description
Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor
Main study:
Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.
Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia | – | Device: SentiCor-300To compare noninvasive continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various positions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.
Key inclusion criteria (7 listed)
- Clinical indication for arterial catheter insertion;
- Age ≥18 years;
- American Society of Anesthesiologists (ASA) physical status class ≤3;
- Enrollment will be adjusted as necessary so the final population includes at least 40% men and 40% women;
- Planned length of surgery >60 minutes;
Key exclusion criteria (12 listed)
- Severe peripheral vascular disease;
- Surgery that involves manipulation of large arteries
- Bypass surgery
- Positive Allen's test
- Inability to insert a catheter into an upper extremity artery;
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 |
|---|---|---|
| SentiCor-300Continuous blood pressure measurement with the SentiCor-300. | Device | Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia |
Primary outcome
Accuracy
Time frame: During hospital admission
The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures.
3 secondary outcomes
Change
Time frame: During hospital admission
Calibration Duration
Time frame: During hospital admission
Gender and Fitzpatrick index
Time frame: During hospital admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- 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.
Alparslan Turan, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by The Cleveland Clinic.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy (time frame: During hospital admission). 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 7 Aug 2023.