PICS Clinical Trial
Official title:
The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients
This prospective observational cohort study will investigate the impact of a bundle of nine preventive measures (Assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and ICU Diary) on the incidence and severity of Post-Intensive Care Syndrome (PICS) and clinical outcomes in critically ill patients
This is a prospective observational cohort study. It will include all adult patients,
admitted to a surgical ICU (13 beds) and a medical ICU (10 beds), with a length of ICU stay
of at least 2 day, from January 01 to December 31 2018. Patients with severe cognitive
deficits prior to admission, identified by clinical history obtained by the psychology or
through the Mental State Mini Exam (MMSE), traumatic brain injury and stroke patients with
Glasgow coma scale <14, will be excluded. On admission to the ICU, risk factors for PICS will
be identified.
During ICU stay, the patients will be submitted to nine interventions aiming at the
prevention of PICS: Assessment, prevention and management of pain; spontaneous awaking trial;
spontaneous breathing trial; choice of sedation and analgesia; delirium assessment,
prevention and management; early mobility; family communication and ICU Diary. At ICU
discharge, the physical, psychiatric and cognitive components of PICS will be evaluated using
the following tools: FSS-ICU, dynamometry and nutritional indicators (physical component),
HADS (Anxiety and Depression), MOCA (cognitive dysfunction) and PCL -C (posttraumatic stress
disorder). The duration of mechanical ventilation, duration of sedation, ICU LOS and hospital
mortality will also be evaluated. Reassessments will be done 5 days after discharge from the
ICU or at hospital discharge (what happens first) and 3 months after the randomization at the
follow-up clinic. Patients identified with PICS at discharge from the ICU will be compared
with those who did not develop the syndrome. The investigators will specifically evaluate the
percentage of adherence to preventive measures, the presence of risk factors and clinical
outcomes.
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