Blood Pressure MeasurementNCT04132453
Continuous Blood Pressure and Waveform Measurements Comparison Between Invasive Arterial Line and PPG Sensor
An observational study of Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- Arterial catheterization kit, GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor and NIBP Cuff (GE Healthcare)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Jun 2018to 31 Mar 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
Who may be able to join
- Signed inform consent
- Age 18-20
- Elective surgery that requires invasive BP monitoring (A-line)
Who cannot join
- Emergency surgery
- Subject has a condition that might prevent BP fluctuations
- Subject is taking medicine that might prevent BP fluctuations
- Arterial line not placed in the radial artery
- Flush test has inadequate frequency response pre-trial
- Subject's arterial line contralateral hand is not available for PPG sensor placement
- Subject has 50% or more pacemaker dependency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line
The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.
Read the detailed description
Before induction of anesthesia, an arterial line will be inserted to the patient radial artery using a designated short, stiff tubing kit according to catheter IFU (Instructions for Use), preferably under US guidance. Removal of air bubbles from the catheter-transducer system is mandatory prior to connecting the tubing to the catheter.
Study nurse will connect a Sensifree laptop with designated data acquisition software (Medicollector BEDSIDE) to the multi-parameter monitor communication port and start the recording of invasive blood pressure and pulse oximeter pleth (PPG sensor) per software IFU. Prior to connecting the arterial line system to the patient, a calibration (flush test) will be done and recorded. During the study, any deterioration in the waveform recorded by the intra-arterial catheter will be noted and appropriate corrective measures will be taken as soon as possible (e.g., flushing or adjusting the position of the catheter).
Preferable NIBP (Non Invasive Blood Pressure) measurement rate will be every 10 minutes, unless the medical procedure requires otherwise.
Calibration procedure will be repeated every 60 +/- 5 minutes and at the end of the surgery. Recording will take place for the duration of the surgery.
NIBP cuff will be placed over the arterial-line arm, NIBP air hose will be replaced with an air hose supplied by Sensifree and the pressure gauge in it will be connected to Sensifree laptop via analog to digital converter in order to capture the data.
Medication used during the surgery will be listed and documented in the CRF (Case Report Form) including drugs name, dose, time and method of administration.
Offline data analysis will compare the blood pressure values as calculated by the Sensifree's algorithm based on the PPG signal, to the values obtained from the arterial line. The comparison results will be measured against the accuracy performance requirements per ISO 81060-2.
- Conditions
- Blood Pressure Measurement
- Being tested
- Arterial catheterization kit, GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor, NIBP Cuff (GE Healthcare)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial catheterization kitDevice
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
GE Datex-Ohmeda Finger Clip Pulse Oximeter SensorDevice
PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
NIBP Cuff (GE Healthcare)Device
A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of waveforms and BP values between PPG sensor and arterial line
Blood pressure waveform will be acquired from the PPG while blood pressure waveform and values (systolic, diastolic, mean) will be acquired from A-line. PPG data will be analyzed by the Sensifree's algorithm and compared to the A-line measurement results according to ISO 81060-2 accuracy specifications
Measured: 3 months after last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start19 Jun 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MeasurementStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensifree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Inbal Dabush-Elisha, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132453
- Sponsor's protocol ID
- CLI-0003.04
- Status last verified
- Oct 2020
- First submitted
- 16 Oct 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensifree's Algorithm for Continuous Blood Pressure Measurements Based on a PPG Sensor's Signal Compared to Invasive Radial Arterial Line
- ClinicalTrials.gov ID
- NCT04132453
- Acronym / sponsor ID
- CLI-0003.04
- Conditions
- Blood Pressure Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sensifree Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 Oct 2019 (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.
The purpose of this study is to compare blood pressure values (systolic, diastolic, mean arterial pressure) and waveform as recorded by a radial arterial line catheter to the waveform and values as calculated by the Sensifree's algorithm from a PPG sensor from a variety group of patients during elective surgeries.
Detailed description
Before induction of anesthesia, an arterial line will be inserted to the patient radial artery using a designated short, stiff tubing kit according to catheter IFU (Instructions for Use), preferably under US guidance. Removal of air bubbles from the catheter-transducer system is mandatory prior to connecting the tubing to the catheter.
Study nurse will connect a Sensifree laptop with designated data acquisition software (Medicollector BEDSIDE) to the multi-parameter monitor communication port and start the recording of invasive blood pressure and pulse oximeter pleth (PPG sensor) per software IFU. Prior to connecting the arterial line system to the patient, a calibration (flush test) will be done and recorded. During the study, any deterioration in the waveform recorded by the intra-arterial catheter will be noted and appropriate corrective measures will be taken as soon as possible (e.g., flushing or adjusting the position of the catheter).
Preferable NIBP (Non Invasive Blood Pressure) measurement rate will be every 10 minutes, unless the medical procedure requires otherwise.
Calibration procedure will be repeated every 60 +/- 5 minutes and at the end of the surgery. Recording will take place for the duration of the surgery.
NIBP cuff will be placed over the arterial-line arm, NIBP air hose will be replaced with an air hose supplied by Sensifree and the pressure gauge in it will be connected to Sensifree laptop via analog to digital converter in order to capture the data.
Medication used during the surgery will be listed and documented in the CRF (Case Report Form) including drugs name, dose, time and method of administration.
Offline data analysis will compare the blood pressure values as calculated by the Sensifree's algorithm based on the PPG signal, to the values obtained from the arterial line. The comparison results will be measured against the accuracy performance requirements per ISO 81060-2.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery involving placement of radial artery A-line for BP monitoring
Key inclusion criteria (3 listed)
- Signed inform consent
- Age 18-20
- Elective surgery that requires invasive BP monitoring (A-line)
Key exclusion criteria (7 listed)
- Emergency surgery
- Subject has a condition that might prevent BP fluctuations
- Subject is taking medicine that might prevent BP fluctuations
- Arterial line not placed in the radial artery
- Flush test has inadequate frequency response pre-trial
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 |
|---|---|---|
| Arterial catheterization kitInvasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform | Device | – |
| GE Datex-Ohmeda Finger Clip Pulse Oximeter SensorPPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform | Device | – |
| NIBP Cuff (GE Healthcare)A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure. | Device | – |
Primary outcome
Comparison of waveforms and BP values between PPG sensor and arterial line
Time frame: 3 months after last patient enrolled
Blood pressure waveform will be acquired from the PPG while blood pressure waveform and values (systolic, diastolic, mean) will be acquired from A-line. PPG data will be analyzed by the Sensifree's algorithm and compared to the A-line measurement results according to ISO 81060-2 accuracy specifications
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 Jun 2022.
- 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.
Inbal Dabush-Elisha, MD principal investigator
Wolfson Medical Center
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 Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in Israel.
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 7 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 Jun 2022. 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 Israel. 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?
Comparison of waveforms and BP values between PPG sensor and arterial line (time frame: 3 months after last patient enrolled). 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 9 Jun 2022.