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Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit

Not Applicable
Terminated
Conditions
Acute Hypercapnic Respiratory Failure
Registration Number
NCT04650412
Lead Sponsor
CTU
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
188
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Hospital readmission1-year observation

Hospital or ICU readmission

Secondary Outcome Measures
NameTimeMethod
Health Related Quality of LifeMeasured at regular 3, 6 and 12 months visits following patient's hospital discharge

Hospital Anxiety and Depression scale (0 to 21 points with 21 indicating higher levels of anxiety and depression) Saint George Questionnaire (0-100 with 100 indicating more limitations) Impact of dyspea on daily activities measured by mMRC (0 to IV with IV indication more impact of dyspnea)

Cost-effectiveness1-year observation

Costs related to unplanned emergency visits and hospital length of stay following readmission

Trial Locations

Locations (3)

Centre Hospitalier Universitaire Grenoble Alpes

🇫🇷

Grenoble, France

Geneva University Hospitals

🇨🇭

Geneva, Switzerland

Centre Hospitalier Universitaire Vaudois

🇨🇭

Lausanne, Switzerland

Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷Grenoble, France
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