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Family Involvement in ICU

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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06770751
Enrollment
122
Registered
2025-01-13
Start date
2025-01-13
Completion date
2025-08-15
Last updated
2025-01-17

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

Conditions

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

Keywords

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

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?

Interventions

None listed

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sedative doseEach 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

MeasureTime frameDescription
DeliriumEach 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 daysEach 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 unitEach 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactOguzhan Kayhan
oguzhan.kayhan@iuc.edu.tr0090 212 414 3000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026