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临床试验/CTRI/2026/02/104971
CTRI/2026/02/104971尚未招募不适用

A prospective, observational study comparing mittens versus wrist restraints in critically ill patients.

Apollo Main Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年3月17日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1

研究概览

简要总结

This is a prospective observational study conducted in the Intensive Care Unit of a tertiary care hospital. The study aims to compare mittens and wrist restraints in critically ill adult patients who require physical limb restraints as part of routine ICU care. All consecutive adult patients of age 18 years and above, who require physical restraints for the first time during their ICU admission will be included in the study during the study period. Patients expected to have an ICU stay of less than 24 hours will be excluded.

The primary outcomes are incidence of unplanned device removal and incidence and severity of restraint site injury assessed using a standardized grading scale. Secondary outcomes include total daily dose of sedative and analgesic medications and number of sedation-free days during the restraint period. Data will be collected prospectively from routine clinical and nursing records without any modification of patient management. Each patient will be followed until discontinuation of restraints, ICU discharge, or death, whichever occurs first.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All consenting adults admitted to the multidisciplinary ICU.
  • Patients who require the application of physical limb restraints ( mittens or wrist restraints) for the first time during their ICU admission.

排除标准

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Patients admitted for an expected ICU stay of less than 24 hours (e.g., for routine post-operative recovery).
  • Patient or family refusal to consent for the clinical application of physical restraints.

研究者

发起方
Apollo Main Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Akhila Bollineni Kumarendra

Apollo Hospitals, Greams Road, Chennai.

研究点 (1)

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