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

Critical Illness Clinical Trial

— CCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851822
• Other study ID #: UModenaReggio3
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2022

Study information

• Verified date: March 2022
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 1, 2022
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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