The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial

Launched by PHILIPS CLINICAL & MEDICAL AFFAIRS GLOBAL · Mar 19, 2025

Keywords

ClinConnect Summary

The HIPULSE Trial is a research study aimed at comparing two methods of measuring blood pressure and fluid responsiveness in patients who have undergone heart surgery or are in a non-cardiac intensive care unit. Specifically, it looks at the Philips AMC device, which is a non-invasive blood pressure cuff, and compares its results to those obtained from a more traditional method using an invasive arterial line placed in the wrist. By conducting this study, researchers hope to determine how well the Philips AMC works in real-world clinical settings.

To participate in this trial, you need to be an adult aged 18 or older who requires a blood pressure cuff and an arterial line. Researchers are especially looking for a diverse group of participants, including older adults and both men and women. If you join the study, you can expect to have your blood pressure monitored using both devices while medical staff ensures your safety and comfort throughout the process. It’s important to note that some individuals may not be eligible, including those with certain medical conditions or specific anatomical factors. This study is not yet recruiting participants, so further details will be provided once it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 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
• Exclusion Criteria:
• • 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
• • 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