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

NCT ID: NCT03398707

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2019-06-30

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.

Conditions

PICS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Sao Domingos

OTHER

Sponsor Role: lead

Responsible Party

José Raimundo Araujo de Azevedo

Director of ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

JOSE R AZEVEDO, MA, PhD

Role: STUDY_CHAIR

DIRECTOR ICU

Locations

Hospital Sao Domingos

São Luís, Maranhão, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20978258 (View on PubMed)

Other Identifiers

PICS study

Identifier Type: -

Identifier Source: org_study_id