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A study comparing hand mittens and wrist restraints in patients admitted to Intensive Care Unit (ICU)

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104971
Enrollment
200
Registered
2026-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R69- Illness, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Apollo Main Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All consenting adults admitted to the multidisciplinary ICU. 2. Patients who require the application of physical limb restraints ( mittens or wrist restraints) for the first time during their ICU admission.

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. Patients admitted for an expected ICU stay of less than 24 hours (e.g., for routine post-operative recovery). 2. Patient or family refusal to consent for the clinical application of physical restraints.

Design outcomes

Primary

MeasureTime frame
1. Comparison of incidence of unplanned device removal 2. Comparison of incidence of restraint site injuryTimepoint: From the time of restraint application until ICU discharge or removal of restraints, whichever is earlier.

Secondary

MeasureTime frame
1. Comparison of sedation requirement 2. Comparison of sedation-free daysTimepoint: From the time of restraint application until ICU discharge or removal of restraints, whichever is earlier.

Countries

India

Contacts

Public ContactAkhila Bollineni Kumarendra

Apollo Hospitals, Greams Road, Chennai.

ajaypadmanaban@gmail.com9840264784

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026