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

NCT ID: NCT02143661

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-11-11

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).

Detailed Description

Delirium is one of the most frequently seen brain organ dysfunctions in the intensive care unit (ICU). Depending on the ICU population, up to 87% have delirium at some point during their critical illness. Patients with delirium have a 3fold increased risk of dying compared to patients without delirium. Studies could show that sedation is the most common independent risk factor for transitioning to delirium. However, the no-sedation approach is often challenging. ICU patients who are not sedated often develop severe anxiety and agitation. These symptoms are often treated with sedatives that have delirogenic side effects.

One of the major reasons for anxiety and agitation of patients is the ICU environment which causes distress. The feelings of being surveyed all the time by monitors, being exposed to different kinds of machinery or equipment which sometimes do not work properly are major stressors.

The objective of the interdisciplinary research project "Parametrische (T)Raumgestaltung" was the development of two redesigned intensive care rooms that help to reduce patients' anxiety, helplessness and stress through a holistic architectural approach. The patient's perception and needs, his or her obvious feelings of helplessness and fear are the starting point for a concept that is able to reduce stress factors such as functional and purely technical environment, insufficient lighting conditions and noise. Minimizing or eliminating these common stress factors in the ICU could reduce the need for sedatives and thereby reducing the incidence of ICU delirium.

Conditions

Intensive Care Unit Environment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill patients in the newly designed ICU rooms

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

No interventions assigned to this group

Critically ill patients in the conventional ICU rooms

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Participation in other clinical studies 10 days before study inclusion and during the study period
• 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)
• History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Spies

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

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

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charité University, Berlin, Germany

Locations

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

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39715945 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38112493 (View on PubMed)

Other Identifiers

Vitality

Identifier Type: -

Identifier Source: org_study_id