eValuatIon of The ALl New Environment for crITicallY Ill Patients (VITALITY)

NCT02143661 | Completed

• 1 other identifier: Vitality
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective observational study is to investigate if mechanically ventilated patients who are treated in one of the new intensive care unit (ICU) rooms have less delirium compared to patients who are treated in the conventional rooms on the same ICU. The investigators will further evaluate the impact on sleep quality, circadian rhythm, global cognitive function and general outcome parameters. The investigators recorded light and noise conditions in the ICU rooms before start of the redesigning process (subproject light and noise in the intensive care unit (LiNo-ICU)). The investigators will compare data regarding light and noise in the ICU rooms before and after the redesigning process (non-patient related data; ethical vote amendment 08.05.2014).

Conditions

Intensive Care Unit Environment

Outcome Measures

Primary Outcomes (1)

• Prevalence of intensive care unit delirium

  Delirium will be measured with the Confusion Assessment Method for the intensive care unit (CAM-ICU)

  Participants will be followed up to 10 days after intensive care unit admission

Secondary Outcomes (34)

• Circadian plasma melatonin level

  Participants will be followed up to 10 days after intensive care unit admission

• Circadian plasma cortisone level

  Participants will be followed up to 10 days after intensive care unit admission

• Gene expression of clock genes in blood monocytes

  Participants will be followed up to 10 days after intensive care unit admission

• Cholinesterase activity in blood

  Participants will be followed up to 10 days after intensive care unit admission

• Core body temperature

  Participants will be followed up to 10 days after intensive care unit admission

Study Arms (2)

Critically ill patients in the newly designed ICU rooms

Critically ill patients treated in one of the newly designed ICU rooms.

Critically ill patients in the conventional ICU rooms

Critically ill patients treated in one of the conventional rooms on the same ICU.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients

You may qualify if:

• Male and female patients with age ≥ 18 years
• Expected intensive Care unit stay ≥ 48 hours
• Invasive mechanical ventilation or non-invasive mechanical ventilation (with positive ventilation pressure \>6 hours/day and high flow \>30 liters) on the day of intensive care unit admission

You may not qualify if:

• Patients with psychiatric diseases
• Patients with a history of stroke and known residual cognitive deficits
• Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
• Analphabetism
• Anacusis or Hypoacusis with hearing aid device, Amaurosis
• Non-German speaking
• Allergies to any substance of the electrode fixing material
• Lacking willingness to save and hand out data within the study
• Accommodation in an institution due to an official or judicial order
• History of sleep disorders
• History or suspicion of hypoxic brain damage (e.g. intracranial bleeding)
• Patients with an open chest after cardiac surgery
• The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
• Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum, Charité- Universitätsmedizin

Berlin, 13353, Germany

Location

Related Publications (2)

• Schmidt S, Heinrich M, Wernecke KD, Spies C, Hancke L, Mueller A, Luetz A. Modification in ICU design may influence circadian serum cholinesterase activities: a proof-of-concept pilot study. Intensive Care Med Exp. 2024 Dec 23;12(1):120. doi: 10.1186/s40635-024-00709-5.

  PMID: 39715945 DERIVED

• Spies C, Piazena H, Deja M, Wernecke KD, Willemeit T, Luetz A; ICU Design Working Group. Modification in ICU Design May Affect Delirium and Circadian Melatonin: A Proof of Concept Pilot Study. Crit Care Med. 2024 Apr 1;52(4):e182-e192. doi: 10.1097/CCM.0000000000006152. Epub 2023 Dec 19.

  PMID: 38112493 DERIVED

Study Officials

• Claudia Spies, MD, Prof.

  Charité University, Berlin, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine, Campus Charité Mitte and Campus Virchow - Klinikum

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 21, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: November 11, 2019
• Last Updated: April 30, 2020

Record last verified: 2020-04

Locations

DE (1)