Family Involvement in ICU

NCT06770751 | Recruiting

• 1 other identifier: 2024/231
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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?

Conditions

Intensive Care Patients; Relatives; Delirium in the Intensive Care Unit; Sedatives; Family

Keywords

Intensive care patients; relatives; Delirium in the intensive care unit; Sedatives

Outcome Measures

Primary Outcomes (1)

• Sedative dose

  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.

  Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

Secondary Outcomes (3)

• Delirium

  Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

• Ventilatory days

  Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

• Stay in intensive care unit

  Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

Study Arms (2)

Short involvement of family

A group where relatives spend up to 2 hours with patients and are involved in their care.

Long involvement of family

A group where relatives spend more than 2 hours with patients and are involved in their care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in a tertiary intensive care unit of a university hospital

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Cerrahpaşa Medical Faculty

Istanbul, 34153, Turkey (Türkiye)

RECRUITING

Study Officials

• Oktay Demirkiran, Professor

  İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty

  STUDY DIRECTOR

• Oguzhan Kayhan

  İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oguzhan Kayhan

CONTACT

0090 212 414 3000; oguzhan.kayhan@iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Lecturer

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 13, 2025
• Study Start: January 13, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)