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Prevalence and Predictors of CCI in Patients With Acute Respiratory Failure (CCI)

Sponsor
University of Modena and Reggio Emilia (Other)
Overall Status
Completed
CT.gov ID
NCT03851822
Collaborator
(none)
127
Enrollment
72
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome [ARDS]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    127 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure
    Actual Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    Feb 1, 2019
    Actual Study Completion Date :
    Jan 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure [60 days from RICU admission]

      The presence of CCI was defined as the need to perform tracheostomy in ICU associated with prolonged MV (the need for ventilatory support for more than 21 consecutive days for at least 6 h per day

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • older than 18 years of age

    • consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.

    Exclusion Criteria:

    • refractory shock (death < 24h)

    • patient goals of care not consistent with aggressive management

    • end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support

    • presence of interstitial lung disease

    • history of neuromuscular disease

    • chest wall deformities

    • pregnancy

    • chemotherapy or radiotherapy within the past 30 days

    • evidence of neurologic injury on CT scan and GCS < 8

    • tracheostomy.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Modena and Reggio Emilia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alessandro Marchioni, Principal Investigator, University of Modena and Reggio Emilia
    ClinicalTrials.gov Identifier:
    NCT03851822
    Other Study ID Numbers:
    • UModenaReggio3
    First Posted:
    Feb 22, 2019
    Last Update Posted:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Critical Illness

    Study Results

    No Results Posted as of Mar 23, 2022