Movement, InvoluntaryNCT05185037
NIBP (Non-invasive Blood Pressure) Algorithm Enhancements (Characterize the Robustness of Motion Artifact Suppression)
An observational study of Movement, Involuntary, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
The study intervention consists of a non-invasive blood pressure (NIBP) measurement device and cuff (FDA-cleared Philips IntelliVue X3 Rev. N.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for NIBP. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Movement, Involuntary
- What is being tested?
- Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2022to 16 Nov 2023
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant Laboring Females scheduled for Caesarean Section Delivery
Who may be able to join
- Obstetric patient at Yale New Haven Hospital
- Receiving epidural anesthesia
- Age at least 18 years
- Willing and able to provide informed consent in a Sponsor approved language
- Willing and able to comply with study-related procedures
- Priority classification II, III, or IV
Who cannot join
- Non-caesarian section deliveries
- Ruptured uterus, prolonged fetal bradycardia, cord prolapse, or other emergent condition
- Procedures under general anesthesia
- Altered mental status
- Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
- Priority classification I or V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NIBP Algorithm Enhancements - MA_PM_NIBP Algorithm Enhancements_2021_11266
The study intervention consists of a non-invasive blood pressure (NIBP) measurement device and cuff (FDA-cleared Philips IntelliVue X3 Rev. N.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for NIBP.
Read the detailed description
The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.
- Conditions
- Movement, Involuntary
- Being tested
- Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)Device
The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Caesarian Section Patient | Obstetric patient Receives: Device: Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIBP measurements with no technical alarms/INOPs
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include no technical alarm (INOP).
Measured: 1 Visit
NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include Diastolic, Systolic, and mean pressures within a physiologically plausible range for the patient population, treatment and medication.
Measured: 1 Visit
NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include pulse pressure greater than 20% of the systolic blood pressure.
Measured: 1 visit
Secondary outcomes (1)
Number of minutes between valid NIBP measurements compared to SoC
The secondary endpoint for this study is the number of minutes between valid measurements for the investigational device as compared to the standard of care device.
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start26 May 2022
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Why it stopped: Business decision with slower than expected enrollment..
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement, InvoluntaryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aymen Alian, MD, Principal investigator, Yale New Haven Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185037
- Sponsor's protocol ID
- MA_PM_NIBP_AE__2021_11266
- Status last verified
- Jun 2023
- First submitted
- 20 Dec 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Philips does not plan to share IPD data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIBP Algorithm Enhancements - MA_PM_NIBP Algorithm Enhancements_2021_11266
- ClinicalTrials.gov ID
- NCT05185037
- Acronym / sponsor ID
- MA_PM_NIBP_AE__2021_11266
- Conditions
- Movement, Involuntary
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision with slower than expected enrollment..
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 11 Jan 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.
The study intervention consists of a non-invasive blood pressure (NIBP) measurement device and cuff (FDA-cleared Philips IntelliVue X3 Rev. N.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for NIBP.
Detailed description
The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caesarian Section Patient | – | Device: Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)Obstetric patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant Laboring Females scheduled for Caesarean Section Delivery
Key inclusion criteria (6 listed)
- Obstetric patient at Yale New Haven Hospital
- Receiving epidural anesthesia
- Age at least 18 years
- Willing and able to provide informed consent in a Sponsor approved language
- Willing and able to comply with study-related procedures
Key exclusion criteria (6 listed)
- Non-caesarian section deliveries
- Ruptured uterus, prolonged fetal bradycardia, cord prolapse, or other emergent condition
- Procedures under general anesthesia
- Altered mental status
- Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
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 |
|---|---|---|
| Philips IntelliVue X3 patient monitor with investigational NIBP measurement algorithm (measured once per 3 minutes)The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia | Device | Caesarian Section Patient |
Primary outcome
NIBP measurements with no technical alarms/INOPs
Time frame: 1 Visit
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include no technical alarm (INOP).
NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication
Time frame: 1 Visit
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include Diastolic, Systolic, and mean pressures within a physiologically plausible range for the patient population, treatment and medication.
NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure
Time frame: 1 visit
The primary endpoint for this study is the rate of NIBP measurements that are valid based on evaluation by a panel of three independent, licensed physicians. Valid measurement will include pulse pressure greater than 20% of the systolic blood pressure.
1 secondary outcome
Number of minutes between valid NIBP measurements compared to SoC
Time frame: 1 visit
Results and safety
The study was stopped early (reason given: Business decision with slower than expected enrollment..). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No. Philips does not plan to share IPD data to other researchers.
Related trials for Movement, Involuntary
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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.
Aymen Alian, MD principal investigator
Yale New Haven Hospital
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 Movement, Involuntary, run by Philips Clinical & Medical Affairs Global 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 5 Jan 2024. 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 was stopped early (reason given: Business decision with slower than expected enrollment..). Results are not available in the source record.
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?
NIBP measurements with no technical alarms/INOPs (time frame: 1 Visit). The study lists 3 primary outcomes in all. 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 5 Jan 2024.