Non-cardiac SurgicalHIPULSENCT06895590
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
An observational study of Non-cardiac Surgical and Intensive Care Unit (ICU), run by Philips Clinical & Medical Affairs Global at 4 sites in 2 countries.
Trial summary
The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-cardiac Surgical, Intensive Care Unit (ICU)
- What is being tested?
- Philips Advanced Monitoring Cuff (i.e. AMC)
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Oct 2025to Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Up to 205 non-cardiac surgical or Intensive Care Unit (ICU) patients being monitored with a radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period.
Who may be able to join
- Adults aged 18 years and older
- Indication for NIBP cuff
- Indication for a radial arterial line
- Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures
- The following stratification criteria must be met across the study sites and hence targeted enrollment may be required:
- Age of every patient 18+; at least 30% > 65 years, 30% ≤ 65 years
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- At least 30% male, 30% female
- Minimum number of subjects needed to test each size cuff (per ISO81060-2:2018/AMD2:2024, based on limb circumference range):
- Adult Small (19-27 cm) = 165*[8/(2*24)] = 28
- Adult (25-34 cm) = 165*[9/(2*24)] = 31
- Adult Large Short (30-40 cm with severely conical arm) = 165*[10/(2*24)] = 35
- Adult Large (32-43 cm) = 165*[11/(2*24)] = 38
- At least 40% of the subjects within each cuff size shall have a limb circumference that lies within the upper half of the specified range of use of the cuff
- At least 40% of the subjects within each cuff size shall have a limb circumference within the lower half of the specified range of use of the cuff
- At least 10% SBP measurements ≤ 100 mmHg
- At least 10% SBP measurements ≥ 160 mmHg
- At least 10% DBP measurements ≤ 70 mmHg
- At least 10% DBP measurements ≥ 85 mmHg
Who cannot join
- Emergency surgery
- Surgeries in which both arms are tucked
- Inability to place the Philips AMC appropriately due to subject anatomy or condition
- Known pregnancy or lactating women (self-report)
- Patients treated with an intra-aortic balloon pump
- Aortic and mitral regurgitation (> 2nd degree), if known
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- Measurements taken in the lateral position
- Pressure of the arterial line system, when tested at 100 mmHg with the VeriCal device, exceeds the +/- 2 mmHg threshold
- Currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
- Upper arm circumference < 19 cm or > 43 cm
- BMI > 45
- If the average of 3 baseline NIBP lateral difference measurements for SBP is > 15 mmHg or for DBP is > 10 mmHg
- At the PI's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Duke University Health System
Durham, North Carolina, 27710
- Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum , Campus Großhadern
München, Bavaria, 81377
About this study
The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
Read the detailed description
Primary Objective:
- To evaluate equivalence of BP measurements (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP], and Mean Arterial Pressure [MAP]) derived from the Philips AMC to the radial arterial line as ground truth.
Secondary Objectives:
- To evaluate equivalence of Pulse Rate (PR) obtained by the Philips AMC to the radial arterial line as the ground truth.
- To evaluate equivalence of Pulse Pressure Variation (PPV) obtained by the Philips AMC to calculated PPV obtained using the radial arterial line waveform pulse pressures as the ground truth.
- To evaluate equivalence of Stroke Volume Variation (SVV) obtained by the Philips AMC to calculated SVV (e.g. from a predicate device that uses the radial arterial line waveform) as the ground truth.
- To evaluate superiority of blood pressure measurements obtained by the Philips AMC to the oscillometric non-invasive blood pressure (NIBP) cuff, with the radial arterial line as the reference.
- To evaluate trending agreement of BP and fluid responsiveness measurements.
- To assess time to apply the Philips AMC relative to the radial arterial line.
- To assess time from set-up start to first measurement completion between the Philips AMC and radial arterial line.
- To collect and report safety data from the Philips AMC.
- To collect and report system user experience and satisfaction scores from Philips AMC users.
- To create a research dataset with the collected data to use for future hemodynamic algorithm development and validation.
Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.
- Conditions
- Non-cardiac Surgical, Intensive Care Unit (ICU)
- Being tested
- Philips Advanced Monitoring Cuff (i.e. AMC)
- Keywords
- BP, FR, DBP, MAP, SBP, A-line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Advanced Monitoring Cuff (i.e. AMC)Device
Investigational, non-invasive upper arm cuff
| Study group | Role | What they receive |
|---|---|---|
| Philips AMC Cuff | This is a non-randomized, single arm, self-controlled observational study. The Philips AMC cuff will be tested on all enrolled participants. Receives: Device: Philips Advanced Monitoring Cuff (i.e. AMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line.
Measured: Approximately 8 months accrual and follow-up evaluation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start2 Oct 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-cardiac SurgicalStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895590
- Sponsor's protocol ID
- BP FR_ AMC vs A-line and NIBP
- Acronym
- HIPULSE
- Status last verified
- Feb 2026
- First submitted
- 19 Mar 2025
- Last updated
- 27 Feb 2026
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
- ClinicalTrials.gov ID
- NCT06895590
- Acronym / sponsor ID
- HIPULSE / BP FR_ AMC vs A-line and NIBP
- Conditions
- Non-cardiac Surgical, Intensive Care Unit (ICU)
- Keywords
- BP, FR, DBP, MAP, SBP, A-line
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 26 Mar 2025 (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 measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
Detailed description
Primary Objective:
- To evaluate equivalence of BP measurements (Systolic Blood Pressure [SBP], Diastolic Blood Pressure [DBP], and Mean Arterial Pressure [MAP]) derived from the Philips AMC to the radial arterial line as ground truth.
Secondary Objectives:
- To evaluate equivalence of Pulse Rate (PR) obtained by the Philips AMC to the radial arterial line as the ground truth.
- To evaluate equivalence of Pulse Pressure Variation (PPV) obtained by the Philips AMC to calculated PPV obtained using the radial arterial line waveform pulse pressures as the ground truth.
- To evaluate equivalence of Stroke Volume Variation (SVV) obtained by the Philips AMC to calculated SVV (e.g. from a predicate device that uses the radial arterial line waveform) as the ground truth.
- To evaluate superiority of blood pressure measurements obtained by the Philips AMC to the oscillometric non-invasive blood pressure (NIBP) cuff, with the radial arterial line as the reference.
- To evaluate trending agreement of BP and fluid responsiveness measurements.
- To assess time to apply the Philips AMC relative to the radial arterial line.
- To assess time from set-up start to first measurement completion between the Philips AMC and radial arterial line.
- To collect and report safety data from the Philips AMC.
- To collect and report system user experience and satisfaction scores from Philips AMC users.
- To create a research dataset with the collected data to use for future hemodynamic algorithm development and validation.
Hypothesis: Blood pressure measurements derived from the Philips AMC are equivalent to the radial arterial line and superior to the oscillometric non-invasive blood pressure (NIBP) cuff.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Philips AMC Cuff | – | Device: Philips Advanced Monitoring Cuff (i.e. AMC)This is a non-randomized, single arm, self-controlled observational study. The Philips AMC cuff will be tested on all enrolled participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 205 non-cardiac surgical or Intensive Care Unit (ICU) patients being monitored with a radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period.
Key inclusion criteria (18 listed)
- Adults aged 18 years and older
- Indication for NIBP cuff
- Indication for a radial arterial line
- Subject or legal authorized representative is able to understand and speak the local language (also Spanish for US sites) to provide voluntary written informed consent prior to study procedures
- The following stratification criteria must be met across the study sites and hence targeted enrollment may be required:
Key exclusion criteria (13 listed)
- Emergency surgery
- Surgeries in which both arms are tucked
- Inability to place the Philips AMC appropriately due to subject anatomy or condition
- Known pregnancy or lactating women (self-report)
- Patients treated with an intra-aortic balloon pump
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 Advanced Monitoring Cuff (i.e. AMC)Investigational, non-invasive upper arm cuff | Device | Philips AMC Cuff |
Primary outcome
Primary Endpoints
Time frame: Approximately 8 months accrual and follow-up evaluation period.
The comparison of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) between the Philips AMC and radial arterial line.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-cardiac Surgical and Intensive Care Unit (ICU), run by Philips Clinical & Medical Affairs Global at 4 sites in 2 countries.
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 18 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lea Egger (+49 1722314318, lea.egger@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoints (time frame: Approximately 8 months accrual and follow-up evaluation period.). 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 27 Feb 2026.