The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectivene… (NCT06895590) | Clinical Trial Compass
RecruitingNot Applicable
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
United States, Germany205 participantsStarted 2025-10-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Phili…
What they're measuring
1
Primary Endpoints
Timeframe: Approximately 8 months accrual and follow-up evaluation period.