Long-term Outcomes in Older Patients With Physical Restraint

Completed

• Conditions: Physical Restraint; Biological Sex Diffrences; Morality

• Registration Number: NCT06491706
• Lead Sponsor: Beaujon Hospital

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

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-03-31
• Study Completion: 2022-10-30
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED were included from November 2019 to March 2021 if PR were mentioned in their medical records

Exclusion Criteria

• if patients were less than 75 years old, without PR or not hospitalized. If a patient was admitted more than once, only the first episode was taken as index admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
one year mortaliy	ONE year

Trial Locations

Locations (1)

Hopital BEAUJON; 🇫🇷 Clichy, France