The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Impact of a Bundle of Preventive Measures for Post-intensive Care Syndrome on the Outcome of Critically Ill Patients

Conditions
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PICS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . Adult non pregnant patients Length of ICU stay of at least 2 days. Exclusion Criteria: Severe cognitive deficits prior to admission. Traumatic brain injury with Glasgow coma scale < 14 Stroke with Glasgow coma scale < 14

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cognitive function | Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool, | Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic | 
| Change in Psychiatric function | Evaluation of psychiatric dysfunction using the HADS (Hospital Anxiety and Depression Scale). | Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic | 
| Change in Post-traumatic stress syndrome | Identification of post-traumatic stress syndrome through PCL-C (Post-traumatic stress checklist-civilian) | Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic | 
| Change in physical function | Evaluation of physical dysfunction through FSS-ICU (Functional status score in the ICU) | Change from baseline at the time of discharge from the ICU, 5 days after discharge from the ICU or at the time of hospital discharge (whichever occurs first) and after 3 months of randomization at the follow-up clinic | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of mechanical ventilation, | The duration of mechanical ventilation in days | During ICU stay.. Expected average 21 days | 
| Duration of sedation | Duration of sedation during ICU stay in days | During ICU stay. Expected average 21 days | 
| ICU LOS | Length of ICU stay in days | During ICU stay. Up to 30 days | 
| Hospital Mortality | Hospital LOS in days | 90 days | 
| Physical function | Measure of handgrip strength though a high precision dynamometer | ICU discharge (baseline) and change from baseline at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICs, diagnosis, prevention, outcome