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OpenTrials
Completed

NCT Number: NCT04042649

Environmental Intervention on Delirious Patients

The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hakjae Lee

Seoul, South Korea

About this study

Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.

Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • with an age of 18 years or older
  • who understood the purpose of this study and agreed to participate
  • stayed in the SICU for a period of 48 hours or longer

Exclusion criteria

  • who remained unresponsive [defined as the Richmond Agitation-Sedation Scale (RASS) less than -4]
  • who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
  • who had a history of severe psychiatric or neurologic deficit
  • who required an isolation room due to transplantation or immunologic compromise
  • who were discharged from ICU within 48 hours
  • who were re-admitted to the ICU
  • who were less than 18 years old
  • who were admitted to the Surgical ICU through another ICU

Treatment and study plan

environmental intervention

Behavioral

provide environmental intervention (help sleep cycle, provide comfortable environment)

Primary outcomes

  1. the incidence rate of delirium

    Time frame: 5 month

  2. time to delirium onset

    Time frame: 5 month

  3. the duration of delirium

    Time frame: 5 month

Secondary outcomes

  1. the number of days of ventilator use

    Time frame: 5 month

  2. the length of stay at the SICU

    Time frame: 5 month

  3. the length of stay at hospital

    Time frame: 5 month

  4. the rate of re-admission to the SICU

    Time frame: 5 month

  5. mortality rate.

    Time frame: 5 month

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

The Effect of Environmental Intervention on Critically-ill Surgical Patients With Delirium

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2019
Registry last updated
Aug 5, 2019

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.

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