Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03398707
Study type Observational [Patient Registry]
Source Hospital Sao Domingos
Contact
Status Completed
Phase
Start date January 25, 2018
Completion date June 30, 2019

See also
  Status Clinical Trial Phase
Completed NCT03717831 - Muscle Dysfunction in Critical Illness
Active, not recruiting NCT05348720 - Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives
Completed NCT04186468 - ICU Follow-up After Prolonged Intensive Care Stay N/A
Recruiting NCT05288140 - Efficacy of the Use of Diaries in Intensive Care Units N/A
Completed NCT05137977 - Is Invasive ICU-treatment Associated With Mental Illness?
Recruiting NCT06020703 - A Study of Healthy Microbiome, Healthy Mind N/A
Recruiting NCT05218083 - REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19 N/A
Completed NCT02739022 - Feasibility Trial of the Early Psychological Support for the Critically Ill N/A