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OpenTrials
Completed

NCT Number: NCT06491706

Long-term Outcomes in Older Patients With Physical Restraint

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.

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Key information

Conditions

Physical Restraint Behavior Coitus Disease Attributes Emergencies Gender Bias Morality Pathologic Processes Pathological Conditions, Signs and Symptoms Prejudice Sexism Sexual Behavior Social Behavior Social Discrimination

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital BEAUJON

Clichy, 92110, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the was no intervention

Other

there was no intervention in this observational study

Primary outcomes

  1. one year mortaliy

    Time frame: ONE year

Sponsors and collaborators

Lead sponsor

Beaujon Hospital

Other

Registry information

Official study title

The Association of Biological Sex and Long-term Outcomes in Older Patients With Physical Restraint at the Emergency Department

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 9, 2024
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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