Effective Volemia in Older Adults With Orthostatic Hypotension

Orthostatic Hypotension Clinical Trial

— EVO  

Official title:

Effective Volemia in Older Adults With Orthostatic Hypotension, Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05304806
• Other study ID #: APHP220078
• Secondary ID: 2021-A03112-39
• Status: Completed
• Start date: April 20, 2022
• Est. completion date: October 21, 2022

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Locations

Country	Name	City	State
France	Geriatric medecine department, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of recording during positional echography	Feasibility of positional echography assessed by; - Duration of recording (minutes)	3 months
Primary	Feasibility of positional echography	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)	3 months
Secondary	Cardiac ultra sound parameters: left ventricle diastolic diameter	- Left ventricle diastolic diameter mm/m2	3 months
Secondary	Cardiac ultra sound parameters: left ventricle ejection fraction	- Left ventricle ejection fraction (%)	3 months
Secondary	Cardiac ultra sound parameters: E and A waves velocity	- E and A waves velocity (cm/sec) (mitral Doppler)	3 months
Secondary	Cardiac ultra sound parameters: Inferior vena cava size and compliance	- Inferior vena cava size (mm) and compliance (%)	3 months
Secondary	Cardiac ultra sound parameters: left atrial size	- Left atrial size (cm2)	3 months