Clinical trial NCT02828722: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation
Keywords: Circadian rhythm
Critical Illness
Mechanical ventilation
Environmental modulation
Lead sponsor: Achros Health Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of the Multiple Organ Dysfunction Score value (delta MODS) from baseline to the end of the study treatment
timeFrame: Over the ICU treatment period but no more than 10 days
Secondary outcomes:
measure: Change of the MODS value (delta MODS) between worst and last score during the study treatment
timeFrame: Over the ICU treatment period but no more than 10 days
measure: Number of participants with gastric retention
timeFrame: over the ICU treatment period but no more than 10 days
measure: Number of participants with delirium
timeFrame: over the ICU treatment period but no more than 10 days
Other outcomes:
measure: Change of the acute physiology and chronic health evaluation II (APACHE II) score from baseline to the end of the study treatment
timeFrame: during study participation but but no more than 10 days
measure: Change of the Sequential Organ Failure Assessment (SOFA) score from baseline to the end of the study treatment
timeFrame: during study participation but but no more than 10 days
measure: Change of the Simplified Acute Physiology II score (SAPS II) score from baseline to the end of the study treatment
timeFrame: during study participation but but no more than 10 days
measure: average daily dose of sedatives
timeFrame: during study participation but but no more than 10 days
measure: length of ICU treatment from admission to discharge in days
timeFrame: during study participation but no more than 99 days
Locations:
city: Szeged
country: Hungary
facility: University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy
Study officials:
References: