This research project started in 2011 thanks to a fund allocated by Lombardy Region for Independent Research, and consists of 4 different parts, called Work Packages (WP); the first (WP1) is carried out in 14 Italian and Swiss centers, the second (WP2) takes place only at San Paolo Hospital in Milan, and the last two (WP3 and WP4) involves eight hospitals in the Milan area already involved in WP1.
Enteral and Intravenous sedation in high-risk critical patient (WP1)
Anxiety and agitation are frequent issues in critically ill patients and are triggered by different causes that include the disease that led the patient to the Intensive Care Unit, the resuscitation department environment and the instrumentation used for the treatment. Sedation is the main tool to make this harsh reality more acceptable to the patient. Sedative targets (how much to keep the patient "awake") and which way (intravenous or enteral) should be used to administer drugs may vary.
The proponents of this project have published two studies to investigate the feasibility and effectiveness of enteral sedation.
Studies have shown that pure enteral sedation is feasible and effective when the goal of sedation is to keep a patient calm, alert and cooperative including periods of physiological sleep.
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Melatonin Pharmacokinetics (WP2)
Melatonin is used to re-estabilish the natural sleep-wake cycle whose alterations contribute to patient's discomfort in the Intensive Care Unit. Its most frequently used way of administration is the enteral one. Recently, slow-release patches have been made available. The purpose of this study is to compare these two ways of administration from the pharmacokinetic point of view.
Training program about validated instruments for operators (WP3)
International guidelines stipulate that in the Intensive Care Unit (ICU) patient's pain level, state of consciousness and acute brain dysfunction should be systemativally evaluated in order to set the most appropriated analgesic and sedative therapy. Often the results of this monitoring can't be reproduced because validated scales are not always available and used.
The purpose of this study is to evaluate the efficacy of a training program for medical and nursing staff about the application of validated instruments for monitoring pain, state of consciousness and acute brain dysfunction.
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Post-traumatic stress after ICU admission (WP4)
Patient discharged from the ICU may develop physical and psychological symptoms after some time.
This condition arises from the perception of the hospitalization in the ICU as a traumatic event. Some studies have shown that the duration of sedation and the use of a sedation protocol both have an impact on the long-term psychological outcome. The main purpose of this research project is to evaluate the efficacy of enterally vs intravenous sedation to obtain the desired level of sedation and to verify if the maintenance of a conscious sedation produces a less prevalence of anxiety and depression.
Part of this Work Package concerns the assessment of post-traumatic stress in people who are in contact with the ICU because of the the hospitalization of a beloved one. This Website has been created to assess if the knowledge of the Intensive Care Unit environment and emotional support may reduce symptoms of anxiety and depression.