An observational study in PICS, sponsored by Hospital Sao Domingos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Hospital Sao Domingos · Observational
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.
Hospital Sao Domingos is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria: .
Exclusion Criteria:
Change in Cognitive function
Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool,
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
The duration of mechanical ventilation,
The duration of mechanical ventilation in days
Time frame: During ICU stay.. Expected average 21 days
Duration of sedation
Duration of sedation during ICU stay in days
Time frame: During ICU stay. Expected average 21 days
ICU LOS
Length of ICU stay in days
Time frame: During ICU stay. Up to 30 days
Hospital Mortality
Hospital LOS in days
Time frame: 90 days
Physical function
Measure of handgrip strength though a high precision dynamometer
Time frame: ICU discharge (baseline) and change from baseline at 3 months
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2018, 11 months.
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Hospital Sao Domingos