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

Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness

• Study Type: Observational
• Enrollment (Actual): 127

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Observational cohort

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure	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	60 days from RICU admission

Collaborators and Investigators

• Sponsor: University of Modena and Reggio Emilia

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: UModenaReggio3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No