Long-term Outcomes in Older Patients With Physical Restraint

NCT ID: NCT06491706

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

149 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-10-30

Brief Summary

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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

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Conditions

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Physical Restraint Gender Bias Morality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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the was no intervention

there was no intervention in this observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beaujon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Prabakar VAITTINADA AYAR

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prabakar VAITTINADA AYAR, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Beaujon

Locations

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Hopital BEAUJON

Clichy, , France

Site Status

Countries

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France

Other Identifiers

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urgBjNpr

Identifier Type: -

Identifier Source: org_study_id

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