Evaluation of the Contribution of Lower Limb And/or Abdominal Compression on Orthostatic Hypotension

Launched by GÉROND'IF · Nov 15, 2024

Keywords

ClinConnect Summary

The HYPOFLEX study is a clinical trial designed to explore how different types of compression garments, like socks and tights, can help people with orthostatic hypotension (OH). OH is a condition where a person's blood pressure drops sharply when they stand up, which can lead to dizziness, falls, and other serious health problems, especially in older adults. This study aims to compare the effectiveness and comfort of various compression methods to improve management of this condition.

To participate in this trial, you must be at least 60 years old and currently hospitalized at Broca Hospital with orthostatic hypotension. You should be able to stand and have been stable for at least 48 hours. Participants will be informed about the study, have their questions answered, and will need to sign a consent form before joining. It’s important to note that if you have certain medical conditions or cognitive impairments, you may not be eligible for the trial. Overall, this study could provide valuable insights into better ways to treat orthostatic hypotension and improve the quality of life for affected individuals.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient aged 60 or over,
• • Patients hospitalized at Broca Hospital with orthostatic hypotension,
• • Patient able to stand,
• • Patient who has been medically stable for at least 48 hours,
• • Patient whose measurements are compatible with Thuasne compression device sizes,
• • Patient having been informed, having received answers to his questions and having signed the informed consent form prior to his participation in the study,
• • Patient affiliated or entitled to a social security number.
• Exclusion Criteria:
• • Patients presenting, according to the investigator, a contraindication to lower limb and/or abdominal compression,
• • Patients presenting any contraindication mentioned in the instructions for use of the medical devices under investigation.
• • Patient presenting, according to the investigator, a major cognitive impairment incompatible with participation in a clinical trial,
• • Patient taking part in another clinical investigation conducted to establish the conformity of a medical device having an impact on the outcomes,
• • Vulnerable patient according to article L1121-6 of the Public Health Code, subject to a judicial protection measure or incapable of consenting to a clinical trial or incapable of giving informed consent.