Blood Pressure MeasurementNCT04456179
Continuous Non-Invasive Blood Pressure System Data Collection in Comparison to Invasive Radial Arterial Pressure
A study testing GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor and Arrow® arterial catheterization kit (Teleflex) in people with Blood Pressure Measurement, run by Sensifree Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor and Arrow® arterial catheterization kit (Teleflex)
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 6 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject with a BMI over 39
- Deformities or abnormalities that may prevent proper application of the device under test
- Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic
- Tachycardia or resting heart rate less than 45 bpm
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
- Subjects with known respiratory conditions such as: (self-reported)
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- uncontrolled / severe asthma,
- flu,
- 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
- Pulsus Paradoxus
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line
The purpose of this study is to evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.
Read the detailed description
On a first visit a screening procedure to verify inclusion / exclusion criteria are met will be conducted. On the primary procedure visit, data collection will begin with the subjects having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed on them for data collection and to monitor their safety for the duration of the study. A physician will place an arterial line in the radial artery. The Sensifree cNIBP system will be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken on the arm opposite the arterial line.
A series of blood pressure changes will be induced, including various combinations of methods.
- Conditions
- Blood Pressure Measurement
- Being tested
- GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor, Arrow® arterial catheterization kit (Teleflex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Arrow® arterial catheterization kit (Teleflex)Device
Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans
Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg):
- Hand grip
- Weight lifting
- Leg static effort
Measured: 3-4 hours per subject
Secondary outcomes (1)
Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device
Comparison of BP values (Systolic, Diastolic, MAP) that are calculated by the investigational device to the BP values measured by the arterial line during isometric effort comprising a combination of the following isometric efforts on a subject's blood pressure:
- Hand grip
- Weight lifting
- Leg static effort
Measured: 3-4 hours per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start3 Feb 2020
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT04456179
- Sponsor's protocol ID
- PR2020-363
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 2 Jul 2020
- 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 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sensifree's PPG Based Continuous & Non-Invasive Blood Pressure Monitoring System in Comparison to Invasive Radial Arterial Line
- ClinicalTrials.gov ID
- NCT04456179
- Acronym / sponsor ID
- PR2020-363
- Conditions
- Blood Pressure Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sensifree Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 2 Jul 2020 (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 evaluate methods to modify blood pressure in humans and measure the effectiveness of such methods. A secondary outcome is to evaluate the performance of an investigational continuous non-invasive blood pressure (cNIBP) device created by Sensifree. The tests will per performed in non-hospitalized subjects under varied controlled conditions that include resting blood pressure and non-pharmacologically induced blood pressure changes.
Detailed description
On a first visit a screening procedure to verify inclusion / exclusion criteria are met will be conducted. On the primary procedure visit, data collection will begin with the subjects having the investigational device, ECG sensors, and 1 or more pulse oximetry sensors placed on them for data collection and to monitor their safety for the duration of the study. A physician will place an arterial line in the radial artery. The Sensifree cNIBP system will be calibrated with an oscillometric and/or auscultatory blood pressure cuff measurement taken on the arm opposite the arterial line.
A series of blood pressure changes will be induced, including various combinations of methods.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (49 listed)
- Subject with a BMI over 39
- Deformities or abnormalities that may prevent proper application of the device under test
- Lateral difference in blood pressure greater than 5mmHg diastolic and 9mmHg systolic
- Tachycardia or resting heart rate less than 45 bpm
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
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 |
|---|---|---|
| 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 | – |
| Arrow® arterial catheterization kit (Teleflex)Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform | Device | – |
Primary outcome
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans
Time frame: 3-4 hours per subject
Measure the effect of a combination of the following isometric efforts on a subject's blood pressure (measured in mmHg): 1. Hand grip 2. Weight lifting 3. Leg static effort
1 secondary outcome
Measure the accuracy of an investigational continuous non-invasive blood pressure (cNIBP) device
Time frame: 3-4 hours per subject
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 2 Jul 2020.
- 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 GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor and Arrow® arterial catheterization kit (Teleflex) 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 2 inclusion and 49 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 2 Jul 2020. 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?
Evaluation of the magnitude of blood pressure change (measured in mmHg) cause by different isometric efforts in humans (time frame: 3-4 hours per subject). 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 2 Jul 2020.