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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

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

Acronym: CCI

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2022
First posted: Feb 22, 2019
Registry last updated: Mar 23, 2022

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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