Family Involvement in ICU

Recruiting

• Conditions: Intensive Care Patients; Relatives; Delirium in the Intensive Care Unit; Sedatives; Family

• Registration Number: NCT06770751
• Lead Sponsor: Istanbul University - Cerrahpasa

Brief Summary

The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.

The main question it aimed to answer was:

Does spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study Start: 2025-01-13
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Patients aged 18 and over.
• Patients with at least one family member actively involved in the care process in the ICU.

Exclusion Criteria

• Patients with pre-existing cognitive impairment or dementia.
• Patients with severe traumatic brain injury.
• Patients with an expected mortality in the ICU of more than 80%.
• Absence of family members for patients admitted to the ICU.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedative dose	Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.	It is the average daily dose of sedative drugs used by a patient. It will be calculated for each sedative drug. It will be calculated by dividing all doses taken by the number of days of hospitalization.

Secondary Outcome Measures

Name	Time	Method
Delirium	Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.	Each patient will be assessed for delirium every day during their hospitalization. CAM-ICU scoring will be used for assessment. The average number of delirium days for each patient will be found by dividing the number of days they were in delirium by the total number of days they were in hospital.
Ventilatory days	Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.	For each patient, the number of days they are on a ventilator will be calculated as a percentage of their length of stay. For each patient, the days they receive invasive ventilation will be divided by the number of days they are treated in the intensive care unit to calculate the percentage.
Stay in intensive care unit	Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.	The length of time each patient stays in intensive care will be recorded.

Trial Locations

Locations (1)

Cerrahpaşa Medical Faculty; 🇹🇷 İstanbul, Turkey