Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 188
- Locations
- 3
- Primary Endpoint
- Hospital readmission
Study Overview
Brief Summary
The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consent form signed
- •Acute hypercapnic respiratory failure defined as PaCO2 > 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU
Exclusion Criteria
- •Age < 18 years old
- •Known or suspected neuromuscular diseases
- •Pregnancy
- •Iatrogenic respiratory failure (i.e. drug overdose, AHRF after starting opiates or increasing opiates dose)
- •Life expectancy < 3 months
- •Confusion or major psychiatric illness
- •Patient unable to be weaned from NIV
Arms & Interventions
Intervention
Bundle of comorbidities care
Intervention: Bundle of comorbidities care (Other)
Control
Standard care
Outcomes
Primary Outcomes
Hospital readmission
Time Frame: 1-year observation
Hospital or ICU readmission
Secondary Outcomes
- Health Related Quality of Life(Measured at regular 3, 6 and 12 months visits following patient's hospital discharge)
- Cost-effectiveness(1-year observation)
Investigators
CTU
Principal investigator
University Hospital, Geneva