ICUCONCT06895603
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
An observational study of ICU and Pulmonary Artery Catheter (PAC), run by Philips Clinical & Medical Affairs Global at 2 sites in 2 countries.
Trial summary
The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter
- What is being tested?
- Philips Advanced Monitoring Cuff (AMC)
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Oct 2025to Jun 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 75 ICU patients being monitored with a PAC and 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 PAC (Swan-Ganz)
- Indication for radial arterial line
- Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures
Who cannot join
- Emergency surgery
- ICU or surgical positioning where 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
- Measurements taken in the lateral position
Show all 10Show fewer
- 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
- 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
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
UVA Health
Charlottesville, Virginia, 22904
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Hamburg Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
The purpose of this study is to compare cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.
- Conditions
- ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter
- Being tested
- Philips Advanced Monitoring Cuff (AMC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips Advanced Monitoring Cuff (AMC)Device
The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue.
| Study group | Role | What they receive |
|---|---|---|
| All patients being monitored with a pulmonary artery catheter | Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study. Receives: Device: Philips Advanced Monitoring Cuff (AMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
The comparison of cardiac output between the Philips AMC and PAC
Measured: Approximately 8 months for accrual and follow-up
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 start28 Oct 2025
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICUStudies 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
- 75 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
- NCT06895603
- Sponsor's protocol ID
- HIPULSE-CO_PAC_2021_11366
- Acronym
- CO
- 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 (Cardiac Output Study)
- ClinicalTrials.gov ID
- NCT06895603
- Acronym / sponsor ID
- CO / HIPULSE-CO_PAC_2021_11366
- Conditions
- ICU, Pulmonary Artery Catheter (PAC), Swan-Ganz Catheter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 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 cardiac output (CO), fluid responsiveness, and related measurements between the Philips AMC and PAC (Swan-Ganz) in ICU or surgical patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients being monitored with a pulmonary artery catheter | – | Device: Philips Advanced Monitoring Cuff (AMC)Up to 75 intensive care unit patients being monitored with a pulmonary artery catheter (approximately 20 patients from at least 2 sites during the roll-in phase and approximately 55 patients during the pivotal phase) will be enrolled over an estimated 8 months accrual and follow-up evaluation period. There will be no randomization in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 75 ICU patients being monitored with a PAC and radial arterial line will be enrolled over approximately 8 months accrual and follow-up evaluation period
Key inclusion criteria (4 listed)
- Adults aged 18 years and older
- Indication for PAC (Swan-Ganz)
- Indication for radial arterial line
- Subject or legal authorized representative is able to understand and speak the local language (also Spanish is also accepted for US sites) to provide voluntary written informed consent prior to study procedures
Key exclusion criteria (10 listed)
- Emergency surgery
- ICU or surgical positioning where 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 (AMC)The Philips AMC is a Class II (USA) and Class IIb (EU) medical device that is a non-invasive, semirigid disposable upper arm cuff with an integrated pneumatic actuator enabling hydraulic coupling of tissue pressure waveforms from the upper arm tissue. | Device | All patients being monitored with a pulmonary artery catheter |
Primary outcome
Primary Endpoints
Time frame: Approximately 8 months for accrual and follow-up
The comparison of cardiac output between the Philips AMC and PAC
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU and Pulmonary Artery Catheter (PAC), run by Philips Clinical & Medical Affairs Global at 2 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 4 inclusion and 10 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 2 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 (+49 172 2314 318, 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 for accrual and follow-up). 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.