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

NCT03851822 | Completed

• 1 other identifier: UModenaReggio3
• Study Type: observational
• Target: 127
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Observational cohort

You may qualify if:

• older than 18 years of age
• consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: January 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: January 1, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03