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

Completed

• Conditions: Critical Illness

• Registration Number: NCT03851822
• Lead Sponsor: University of Modena and Reggio Emilia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2019-02-01
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Study Completion: 2022-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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