Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm

Achros Health Technologies

Status: Unknown

Conditions: Critical Illness; Mechanical Ventilation

Treatments: Other: Controlled light and noise; Other: Controlled nutrition

Study type: Interventional

Funder types: Industry

Identifiers

NCT02828722

ACHROS CRC-003

Details and patient eligibility

About

The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.

Full description

The homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. Intensive Care Unit (ICU) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. There are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. Although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. If the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic.

ICU environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. It has been shown that ICU settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. There are significant data showing strong correlation between delirium and ICU length of stay/ mortality.

The focus of this study is the environmental modulation at the ICU with controlled light, noise and nutrition conditions. Controlled light conditions are created with artificial light during daytime and sleeping mask during night time. Earplugs are used during night time for controlled noise conditions. Nutrition is carried out only during daytime both in case of enteral and parenteral feeding.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years or older
• Requiring treatment at the intensive care unit including mechanical ventilation
• Admission at the intensive care unit was done within 24 hours before randomization
• Written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative

Exclusion criteria

• Traumatic brain injury
• Multiple trauma
• Severe damage of the eye/optic nerve
• Blindness
• Post CPR
• Unlikely to survive 24 hours
• Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)
• Intracranial space occupying process
• Increased intracranial pressure
• Narcolepsy
• Huntington's disease
• Hypothermia
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Controlled light, noise and nutrition

Experimental group

Description:

Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the nutrition protocol corresponding to the daily rhythm will be applied.

Treatment:

Other: Controlled nutrition

Other: Controlled light and noise

Controlled light and noise

Experimental group

Description:

Simultaneously with the standard treatment performed at the clinical trial site environmental simulation of night time and daytime alternation as well as the continuous nutrition (in accordance with the clinical trial site's standard practice) will be applied.

Treatment:

Other: Controlled light and noise

Control

No Intervention group

Description:

The treatment of the study subject will be performed based on the clinical trial site's standard practice without environmental simulation or changes in the nutrition protocol.