Viewing Study NCT06491706


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Ignite Modification Date: 2025-12-26 @ 2:43 PM
Study NCT ID: NCT06491706
Status: COMPLETED
Last Update Posted: 2025-07-25
First Post: 2024-07-01
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Long-term Outcomes in Older Patients With Physical Restraint
Sponsor: Beaujon Hospital
Organization:

Study Overview

Official Title: The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department
Status: COMPLETED
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The worldwide population is ageing. Biological sex is first and foremost a genetic modifier of disease. To prevent self-arm many techniques can be used in older patients. Among them coercive measure consisting of physical restraint (PR) is one of the techniques.

This study aims to assess the effects of the biological sex on the long-term survival after PR in geriatric patients during the initial emergency department (ED) visit.

This retrospective study included patients between November 2019 to March 2021. All consecutive hospitalized patients after emergency department visit older than 75 years with PR were included.

The population was compared according to the biological sex. One-year all-cause mortality was plotted with the Kaplan-Meier curve. Hazard ratios (HRs) for 1-year mortality were calculated using a Cox proportional hazards regression model. Mortality was monitored over a 3-year period.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: