Family Involvement in ICU

January 15, 2025 updated by: Oguzhan Kayhan, Istanbul University - Cerrahpasa

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.

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?

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İstanbul, Turkey, 34153
        • Recruiting
        • Cerrahpasa Medical Faculty
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients in a tertiary intensive care unit of a university hospital

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
The length of time each patient stays in intensive care will be recorded.
Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Study Director: Oktay Demirkiran, Professor, İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
  • Principal Investigator: Oguzhan Kayhan, İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethics committee approval was not obtained for sharing patient data with an international database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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