Long-term Outcomes in Older Patients With Physical Restraint

NCT06491706 | Completed

• 1 other identifier: urgBjNpr
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Restraint; Gender Bias; Morality

Keywords

physical restraint; emergency department; biological sex; long-term mortality

Outcome Measures

Primary Outcomes (1)

• one year mortaliy

  ONE year

Interventions

the was no intervention OTHER

there was no intervention in this observational study

Eligibility Criteria

• Age: 75 Years+
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive older patients ≥ 75-year-old

You may qualify if:

• All consecutive older patients ≥ 75-year-old hospitalized to the observation unit or to the ward from the ED
• If physical restraint were mentioned in medical records

You may not qualify if:

• if patients were less than 75 years old
• Without physical restraint
• Not hospitalized
• If a patient was admitted more than once, only the first episode was taken as index admission

Sponsors & Collaborators

• Beaujon Hospital: lead

Study Sites (1)

Hopital BEAUJON

Clichy, 92110, France

Location

MeSH Terms

Conditions

Sexism; Emergencies; Coitus

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior

Study Officials

• Prabakar VAITTINADA AYAR, MD, PhD

  Hôpital Beaujon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: November 1, 2019
• Primary Completion: March 31, 2021
• Study Completion: October 30, 2022
• Last Updated: July 25, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)