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

NAUnknownINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

April 30, 2017

Study Completion Date

June 30, 2017

Conditions
Critical IllnessMechanical Ventilation
Interventions
OTHER

Controlled light and noise

"Purpose: The day-night ratio of the environmental illumination (limit 8 lux) and that of the noise level (limit 20 dBA) must correspond to the necessary value required by a healthy human body as defined by the National Sleep Foundation (USA).~Implementation: Simulation of the daytime period is performed with blue predominant artificial light with colour temperature between 5500 and 8000 K with lux values of 1000-1200 measured at the head of the patient. Simulation of the nighttime period is performed with a sleeping mask and earplugs."

OTHER

Controlled nutrition

"In compliance with the standard daily nutrition protocol, nutrition is carried out only during daytime both in case of enteral and parenteral feeding in accordance with European Society for Clinical Nutrition and Metabolism 2016 guidelines.~Nutritional regimen should be stopped for 8 hours/24 at night (non-nutritional period may be depending on the work schedule of the actual ICU) , even if the daily energy/protein target is not reached."

Trial Locations (1)

Unknown

University of Szeged Faculty of Medicine, Department of Anaesthesiology and Intensive Therapy, Szeged

All Listed Sponsors
lead

Achros Health Technologies Corporation

INDUSTRY

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 | Biotech Hunter | Biotech Hunter