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NCT04650412 Clinical Trial

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

Acute Hypercapnic Respiratory Failure Clinical Trial

— TMIRA  

Official title:
Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04650412
Other study ID # 2016-01879
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 28, 2018
Est. completion date July 31, 2022

Study information
Verified date May 2023
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 188
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Bundle 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

Locations
Country Name City State
France Centre Hospitalier Universitaire Grenoble Alpes Grenoble
Switzerland Geneva University Hospitals Geneva
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne

Sponsors (2)
Lead Sponsor Collaborator
CTU Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital readmission Hospital or ICU readmission 1-year observation
Secondary Health Related Quality of Life 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) Measured at regular 3, 6 and 12 months visits following patient's hospital discharge
Secondary Cost-effectiveness Costs related to unplanned emergency visits and hospital length of stay following readmission 1-year observation
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