Effective Volemia in Older Adults With Orthostatic Hypotension

Completed

• Conditions: Orthostatic Hypotension

• Registration Number: NCT05304806
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults.

The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients.

The secondary objectives are to assess the variability of measurements between decubitus and sitting position.

Detailed Description

This is a monocentric study. Twenty patients will be enrolled, aged of 70 years and older. POCUS parameters, duration of procedure and measurements will be recorded for each patients.

Study Timeline

• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Study Start: 2022-04-20
• Primary Completion: 2022-10-21
• Study Completion: 2022-10-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 70 years and older
• Orthostatic hypotension or venous insufficiency
• Affiliated to a social security or beneficiary

Exclusion Criteria

• Refusal to participation to the study
• Cognitive disorder
• Unable to keep sitting posture for up to 30 minutes
• Foreign patients under french AME scheme

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of recording during positional echography	3 months	Feasibility of positional echography assessed by; - Duration of recording (minutes)
Feasibility of positional echography	3 months	Feasibility of positional echography assessed by; - Number of good quality imaging (out of 5 pre specified views : parasternal long axis view, parasternal short axis view, apical views 4 and 5 chamber, subxiphoid view, inferior vena cava view)

Secondary Outcome Measures

Name	Time	Method
Cardiac ultra sound parameters: left ventricle diastolic diameter	3 months	- Left ventricle diastolic diameter mm/m2
Cardiac ultra sound parameters: left ventricle ejection fraction	3 months	- Left ventricle ejection fraction (%)
Cardiac ultra sound parameters: Inferior vena cava size and compliance	3 months	- Inferior vena cava size (mm) and compliance (%)
Cardiac ultra sound parameters: left atrial size	3 months	- Left atrial size (cm2)
Cardiac ultra sound parameters: E and A waves velocity	3 months	- E and A waves velocity (cm/sec) (mitral Doppler)

Trial Locations

Locations (1)

Geriatric medecine department, Ambroise Paré hospital, APHP; 🇫🇷 Boulogne-Billancourt, France