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Recruiting NCT06770751

Family Involvement in ICU

Observational Intensive Care Patients Relatives Delirium in the Intensive Care Unit Sedatives

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intensive Care Patients, Relatives, Delirium in the Intensive Care Unit, Sedatives. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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.

Overview

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?

Primary outcome measures

  • Sedative dose [Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.]
Secondary outcome measures (3)
  • Delirium [Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.]
  • Ventilatory days [Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.]
  • Stay in intensive care unit [Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • Cerrahpaşa Medical Faculty — Istanbul

Identifiers

NCT: NCT06770751 · 2024/231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗