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Clinical Trials/NCT06770751
NCT06770751
Recruiting
Not Applicable

Family Involvement in the Intensive Care Unit: a Prospective Cohort Study Exploring Its Effects on Sedation Dosages, Delirium, Ventilator-Free Days, and Length of Stay.

Istanbul University - Cerrahpasa1 site in 1 country122 target enrollmentJanuary 13, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Patients
Sponsor
Istanbul University - Cerrahpasa
Enrollment
122
Locations
1
Primary Endpoint
Sedative dose
Status
Recruiting
Last Updated
last year

Overview

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?

Registry
clinicaltrials.gov
Start Date
January 13, 2025
End Date
August 15, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Oguzhan Kayhan

Medical Doctor, Lecturer

Istanbul University - Cerrahpasa

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Sedative dose

Time Frame: 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 Outcomes

  • 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 Sites (1)

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