ClinConnect ClinConnect Logo
Search / Trial NCT06999863

Oscillometric Blood Pressure Measurement: Evaluation of the Effect of Wearing a Sleeve and the Type of Measurement Algorithm

Launched by NANTES UNIVERSITY HOSPITAL · May 23, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Blood Pressure Determination (Me Sh) Bare Arm Sleeve Measurement Algorithm Catheterization, Peripheral Arterial (Me Sh) Cuff Oscillometry (Me Sh)

ClinConnect Summary

The CASBA study is looking at how wearing a sleeve over the arm affects the accuracy of blood pressure measurements taken with an automated device in patients in intensive care units. Usually, the blood pressure cuff should be placed directly on bare skin for the best results. This study will help determine if putting the cuff over clothing changes the readings and will also compare two different ways (algorithms) of measuring blood pressure to see which one works better in these settings.

To participate in the study, patients need to be adults aged 18 and older who have a catheter in their radial artery and whose blood pressure has been stable for at least five minutes. However, certain conditions like heart rhythm problems, arm injuries, or being pregnant may prevent someone from joining. Participants will be closely monitored, and their blood pressure readings will be taken using the different methods being tested. This research aims to improve how blood pressure is measured in critically ill patients, which can help doctors provide better care.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • - Patients having a catheter in the radial artery.
  • and with stable BP over a 5-min period (no change in invasive MBP \>10% and no change in vasoactive drugs)
  • Exclusion Criteria:
  • - Cardiac arrhythmia.
  • Dysfunctional of the arterial catheter or waveform, suggesting signal over- or under-damping.
  • Arm circumference \> 42 cm (measured at mid-arm).
  • Contraindication to BP measurement on the arm (fracture, wound, amputated limb, limb ischemia, infection, phlebitis, history of lymph node dissection, venous access on the limb preventing cuff inflation, other).
  • Patient's health status requiring urgent care incompatible with study protocol.
  • Asymmetry of MBP between the two arms (\>5 mmHg) or inability to check it.
  • Pregnant woman.
  • Age \<18 years old.
  • Adult known to be under guardianship or legal supervision before inclusion.
  • Absence of social security coverage.
  • Non-French speaker patient (i.e. unable to receive study information)

About Nantes University Hospital

Nantes University Hospital, a leading academic medical institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific exploration with patient care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a strong emphasis on ethical standards and patient safety, Nantes University Hospital aims to contribute to the development of effective therapies and interventions that enhance patient outcomes and overall public health.

Locations

Nantes, , France

Patients applied

0 patients applied

Trial Officials

Karim LAKHAL, PH

Principal Investigator

Nantes University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported