Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06770751

Family Involvement in ICU

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?

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cerrahpaşa Medical Faculty

Istanbul, 34153, Turkey (Türkiye)

Location status: Recruiting

Location contact

Oguzhan Kayhan

CONTACT

[email protected]

0090 212 414 3000 ext. 63943

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Delirium

    Time frame: 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.

  2. Ventilatory days

    Time frame: 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.

  3. 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.

    The length of time each patient stays in intensive care will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Oguzhan Kayhan

CONTACT

[email protected]

0090 212 414 3000 ext. 63943

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.