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Completed

NCT Number: NCT03398707

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

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

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Key information

Conditions

PICS Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sao Domingos

São Luís, Maranhão, 65060-642, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Cognitive function

    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

    Evaluation of cognitive dysfunction using the Montreal Cognitive Assessment (MOCA) tool,

  2. Change in Psychiatric function

    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

    Evaluation of psychiatric dysfunction using the HADS (Hospital Anxiety and Depression Scale).

  3. Change in Post-traumatic stress syndrome

    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

    Identification of post-traumatic stress syndrome through PCL-C (Post-traumatic stress checklist-civilian)

  4. Change in physical function

    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

    Evaluation of physical dysfunction through FSS-ICU (Functional status score in the ICU)

Secondary outcomes

  1. The duration of mechanical ventilation,

    Time frame: During ICU stay.. Expected average 21 days

    The duration of mechanical ventilation in days

  2. Duration of sedation

    Time frame: During ICU stay. Expected average 21 days

    Duration of sedation during ICU stay in days

  3. ICU LOS

    Time frame: During ICU stay. Up to 30 days

    Length of ICU stay in days

  4. Hospital Mortality

    Time frame: 90 days

    Hospital LOS in days

  5. Physical function

    Time frame: ICU discharge (baseline) and change from baseline at 3 months

    Measure of handgrip strength though a high precision dynamometer

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 12, 2018
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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