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

Completed

• Conditions: PICS

• Registration Number: NCT03398707
• Lead Sponsor: Hospital Sao Domingos

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.

Study Timeline

• Study First Submitted: 2017-12-24
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-12
• Study Start: 2018-01-25
• Status Verified: 2018-12
• Primary Completion: 2018-12-31
• Last Update Submitted: 2019-06-29
• Study Completion: 2019-06-30
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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• Adult non pregnant patients
• Length of ICU stay of at least 2 days.

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Exclusion Criteria

• Severe cognitive deficits prior to admission.
• Traumatic brain injury with Glasgow coma scale < 14
• Stroke with Glasgow coma scale < 14

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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)
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)

Secondary Outcome Measures

Name	Time	Method
The duration of mechanical ventilation,	During ICU stay.. Expected average 21 days	The duration of mechanical ventilation in days
ICU LOS	During ICU stay. Up to 30 days	Length of ICU stay 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
Hospital Mortality	90 days	Hospital LOS in days

Trial Locations

Locations (1)

Hospital Sao Domingos; 🇧🇷 Sao Luis, MA, Brazil