PICS
Conditions
Keywords
PICs, diagnosis, prevention, outcome
Brief summary
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
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.
Interventions
None listed
Sponsors
Hospital Sao Domingos
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive function | 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 | Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool, |
| Change in Psychiatric function | 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 | Evaluation of psychiatric dysfunction using the HADS (Hospital Anxiety and Depression Scale). |
| Change in Post-traumatic stress syndrome | 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 | Identification of post-traumatic stress syndrome through PCL-C (Post-traumatic stress checklist-civilian) |
| Change in physical function | 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 | Evaluation of physical dysfunction through FSS-ICU (Functional status score in the ICU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The duration of mechanical ventilation, | During ICU stay.. Expected average 21 days | The duration of mechanical ventilation in days |
| Physical function | ICU discharge (baseline) and change from baseline at 3 months | Measure of handgrip strength though a high precision dynamometer |
| Duration of sedation | During ICU stay. Expected average 21 days | Duration of sedation during ICU stay in days |
| ICU LOS | During ICU stay. Up to 30 days | Length of ICU stay in days |
| Hospital Mortality | 90 days | Hospital LOS in days |
Countries
Brazil
Outcome results
None listed