Blood Pressure MeasurementNCT04100668
Evaluation of Sensifree's Alpha Sensor Signal Morphology Compared to Arterial Line and PPG Signal Morphologies
A study testing Sensifree's Alpha sensor, Arrow® arterial catheterization kit (Teleflex) and GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor in people with Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in United States.
Trial summary
The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- Sensifree's Alpha sensor, Arrow® arterial catheterization kit (Teleflex) and GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 29 Sep 2017
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General:
- Subject must have the ability to understand and provide written informed consent
- Subject must be willing and able to comply with study procedures and duration
- Screening and Phase 1:
- Subject is from 20 to 55 years old.
- Subject has wrist circumference size within 145 and 220mm for both arms.
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- Subjects with lateral blood pressure difference (auscultatory cuff based measurement) is less than: 15 mmHg for systolic blood pressure. 10 mmHg for diastolic blood pressure.
- Subjects with investigational device signal quality higher than a predefined value
- Subjects with similar investigational devices signals between their two arms.
- Phase 2 (all requirements as Phase 1 except):
- Subject is from 20 to 85 years old.
- At least 60% of subjects will have hypertensive blood pressure values (goal) (systolic >140 mmHg and/or diastolic >90 mmHg)
- At least 15% of subjects will have hypotensive blood pressure values (goal) (systolic <110 mmHg and/or diastolic <60 mmHg).
- No more than 25% of subjects will have normotensive blood pressure values (goal) (systolic from 110 to 140 mmHg and/or diastolic from 60 to 90 mmHg).
Who cannot join
- Subject with a BMI over 39
- Deformities or abnormalities that may prevent proper application of the device under test
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Subjects with known respiratory conditions such as: (self-reported)
- uncontrolled / severe asthma,
- flu,
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- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, COPD, lung disease
- Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- have had cardiovascular surgery
- have cardiac pacemakers and/or automatic internal cardio-defibrillator
- Chest pain (angina)
- Abnormal pulse pressure
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- Subject with a heart rate of less than 45 BPM
- Self-reported health conditions as identified in the Health Assessment Form (self- reported)
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury
- cancer / chemotherapy
- Subjects with known clotting disorders (self-reported)
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- current use of blood thinner: prescription or daily use of aspirin
- Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Subjects with a contact allergy to ultrasound gel.
- Subjects with prior or known allergies to iodine or lidocaine (or similar pharmacological agents, e.g. Novocaine)
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test
- Subject is intoxicated during the time of the visit, or was intoxicated within 24 hours prior to study visit, as reported by the subject, or per study staff judgment.
- Other known health condition, should be considered upon disclosure in health assessment form
- Subjects with heart rate below 45 BPM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sensifree's Alpha Sensor Signal Morphology in Comparison to Invasive Radial Arterial Line Pressure Waveform and PPG Signal Morphology
The purpose of the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter.
The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.
Read the detailed description
This study is a single-center, non-randomized study with a maximum of 50 subjects. The duration of the study for each subject test is expected to take approximately 3 hours: 1 hour for screening (Visit 1) and 2 hours for data collection (Visit 2).
Data Collection, Visit 2, will be divided into two phases. Phase 1 will use up to 20 subjects with the goal of collecting data for algorithm and sensor development. No requirements for certain blood pressure populations are required for Phase 1. Once the analysis of the Phase 1 results is complete, Phase 2 will use up to 30 subjects with the following requirements to test multiple blood pressure populations:
- No more than 25% will be normotensive
- At least 60% of the subjects will be hypertensive
- At least 15% of the subjects will be hypotensive
Visit 1- Screening Screening will be identical for both phases of the study. Subjects will be screened for per the inclusion criteria, assuring the subject will be a good candidate for the data collection portion of the study. If the subject does not meet the inclusion criteria they will not be invited to participate in Visit 2. During screening, the subject's wrist circumference will be recorded and measured for each arm. The clinician will perform auscultatory blood pressure measurements on both arms to determine the lateral systolic and diastolic blood pressure difference per Procedure 5.2.4.3.1. in the International Standards Organization (ISO) 81060-2:2013. Using ultrasound, the clinician will also determine if the subject has any bifurcations in the radial artery of each arm. Finally, the investigation devices will be place on both wrists of the subject to determine if adequate signal can be detected. If the subject meets all the inclusion criteria for screening they will be invited to participate in the data collection portion of the study during Visit 2.
Visit 2- Screening Visit 2, the data collection portion of the study, will begin with the volunteer test subject lying in the supine position. The subject will be reminded they may withdraw from the study at any time. The subject will have the investigational device, ECG sensors, and a pulse oximetry sensor placed on them for data collection and to monitor their safety for the duration of the study. An arterial line will be placed in the radial artery, contralateral to the investigational device, under sterile conditions by a physician. To begin data collection; 10 minute periods of simultaneous invasive data from the arterial line and the non-invasive signal from the investigational device will be recorded. Once the supine recording sessions are complete, the subject will be raised to a seated position and the pressure transducer will be recalibrated. The subject will then vary both their arm positions simultaneously from heart level, to above heart level, and to below heart level to record the changes in pressure due to movement.
Once all data has been collected, the radial arterial catheter will be removed by the physician and constant pressure held on the arterial puncture for a minimum of 10 minutes. The clinician will review any final questions with the subject, the subject will be provided with phone numbers for questions pertaining to the participation in this study or research-related injury or reaction post study. Follow-up with each subject will be conducted within 5 days following participation in the study and will be conducted via telephone, text, or email.
- Conditions
- Blood Pressure Measurement
- Being tested
- Sensifree's Alpha sensor, Arrow® arterial catheterization kit (Teleflex), GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensifree's Alpha sensorDevice
RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform
Arrow® arterial catheterization kit (Teleflex)Device
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter SensorDevice
PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Experimental | Comparing radial arterial line, Sensifree's Alpha sensor and PPG sensor pressure waveforms Receives: Device: Sensifree's Alpha sensor; Device: Arrow® arterial catheterization kit (Teleflex); Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of signals acquired from the investigational device, pulse oximeter, and arterial line
BP waveform will be acquired form three sources (PPG, A-line and investigational device),data will be statistically analyzed to find the correlations between the different sources of BP waveform
Measured: Three hours
Secondary outcomes (1)
Evaluation of waveform signal changes with different arm positions
Recordings will be made using the investigational device with different position of the subject arm to assess the effect of the arm positions (arm up, down and in chest level) over the acquired BP waveform signal
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start26 Sep 2017
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensifree Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Ruiz Cabrera, M.D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100668
- Sponsor's protocol ID
- PR2017-240
- Status last verified
- Sep 2019
- First submitted
- 28 Mar 2018
- Last updated
- 24 Sep 2019
- 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 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensifree's Alpha Sensor Signal Morphology in Comparison to Invasive Radial Arterial Line Pressure Waveform and PPG Signal Morphology
- ClinicalTrials.gov ID
- NCT04100668
- Acronym / sponsor ID
- PR2017-240
- Conditions
- Blood Pressure Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sensifree Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 24 Sep 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 the protocol is to compare Sensifree Alpha sensor signal morphology, measured at the radial artery, to an invasive arterial line pressure signal and the oxygen saturation as read by a pulse oximeter.
The study will be split into two phases: the first phase will collect data for morphology analysis and algorithm development, the second phase will compare device performance to the reference invasive blood pressures. A secondary objective is to evaluate signal morphology changes due to changes in subject arm position.
Detailed description
This study is a single-center, non-randomized study with a maximum of 50 subjects. The duration of the study for each subject test is expected to take approximately 3 hours: 1 hour for screening (Visit 1) and 2 hours for data collection (Visit 2).
Data Collection, Visit 2, will be divided into two phases. Phase 1 will use up to 20 subjects with the goal of collecting data for algorithm and sensor development. No requirements for certain blood pressure populations are required for Phase 1. Once the analysis of the Phase 1 results is complete, Phase 2 will use up to 30 subjects with the following requirements to test multiple blood pressure populations:
- No more than 25% will be normotensive
- At least 60% of the subjects will be hypertensive
- At least 15% of the subjects will be hypotensive
Visit 1- Screening Screening will be identical for both phases of the study. Subjects will be screened for per the inclusion criteria, assuring the subject will be a good candidate for the data collection portion of the study. If the subject does not meet the inclusion criteria they will not be invited to participate in Visit 2. During screening, the subject's wrist circumference will be recorded and measured for each arm. The clinician will perform auscultatory blood pressure measurements on both arms to determine the lateral systolic and diastolic blood pressure difference per Procedure 5.2.4.3.1. in the International Standards Organization (ISO) 81060-2:2013. Using ultrasound, the clinician will also determine if the subject has any bifurcations in the radial artery of each arm. Finally, the investigation devices will be place on both wrists of the subject to determine if adequate signal can be detected. If the subject meets all the inclusion criteria for screening they will be invited to participate in the data collection portion of the study during Visit 2.
Visit 2- Screening Visit 2, the data collection portion of the study, will begin with the volunteer test subject lying in the supine position. The subject will be reminded they may withdraw from the study at any time. The subject will have the investigational device, ECG sensors, and a pulse oximetry sensor placed on them for data collection and to monitor their safety for the duration of the study. An arterial line will be placed in the radial artery, contralateral to the investigational device, under sterile conditions by a physician. To begin data collection; 10 minute periods of simultaneous invasive data from the arterial line and the non-invasive signal from the investigational device will be recorded. Once the supine recording sessions are complete, the subject will be raised to a seated position and the pressure transducer will be recalibrated. The subject will then vary both their arm positions simultaneously from heart level, to above heart level, and to below heart level to record the changes in pressure due to movement.
Once all data has been collected, the radial arterial catheter will be removed by the physician and constant pressure held on the arterial puncture for a minimum of 10 minutes. The clinician will review any final questions with the subject, the subject will be provided with phone numbers for questions pertaining to the participation in this study or research-related injury or reaction post study. Follow-up with each subject will be conducted within 5 days following participation in the study and will be conducted via telephone, text, or email.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data collection | Experimental | Device: Sensifree's Alpha sensor, Device: Arrow® arterial catheterization kit (Teleflex), Device: GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter SensorComparing radial arterial line, Sensifree's Alpha sensor and PPG sensor pressure waveforms |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- General:
- Screening and Phase 1:
- Phase 2 (all requirements as Phase 1 except):
Key exclusion criteria (48 listed)
- Subject with a BMI over 39
- Deformities or abnormalities that may prevent proper application of the device under test
- Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
- Subjects with known respiratory conditions such as: (self-reported)
- Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
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 |
|---|---|---|
| Sensifree's Alpha sensorRF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform | Device | Data collection |
| Arrow® arterial catheterization kit (Teleflex)Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform | Device | Data collection |
| GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter SensorPPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform | Device | Data collection |
Primary outcome
Comparison of signals acquired from the investigational device, pulse oximeter, and arterial line
Time frame: Three hours
BP waveform will be acquired form three sources (PPG, A-line and investigational device),data will be statistically analyzed to find the correlations between the different sources of BP waveform
1 secondary outcome
Evaluation of waveform signal changes with different arm positions
Time frame: Three 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 24 Sep 2019.
- 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.
Arthur Ruiz Cabrera, M.D principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensifree's Alpha sensor, Arrow® arterial catheterization kit (Teleflex) and GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor in people with Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in United States.
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 14 inclusion and 48 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 24 Sep 2019. 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 United States. 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 signals acquired from the investigational device, pulse oximeter, and arterial line (time frame: Three hours). 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 24 Sep 2019.