Acute Hypercapnic Respiratory Failure
Conditions
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.
Interventions
OTHERBundle of comorbidities care
Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge
Sponsors
Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
CTU
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial (bundle of comorbidity care vs standard care)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital readmission | 1-year observation | Hospital or ICU readmission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | Measured 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-effectiveness | 1-year observation | Costs related to unplanned emergency visits and hospital length of stay following readmission |
Countries
France, Switzerland
Outcome results
None listed