Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit (TMIRA)
Primary Purpose
Acute Hypercapnic Respiratory Failure
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bundle of comorbidities care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire Grenoble Alpes
- Geneva University Hospitals
- Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Bundle of comorbidities care
Standard care
Outcomes
Primary Outcome Measures
Hospital readmission
Hospital or ICU readmission
Secondary Outcome Measures
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)
Cost-effectiveness
Costs related to unplanned emergency visits and hospital length of stay following readmission
Full Information
NCT ID
NCT04650412
First Posted
November 18, 2020
Last Updated
May 10, 2023
Sponsor
CTU
Collaborators
Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
1. Study Identification
Unique Protocol Identification Number
NCT04650412
Brief Title
Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
delayed recruitment and lack of refinancing
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
CTU
Collaborators
Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypercapnic Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial (bundle of comorbidity care vs standard care)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Bundle of comorbidities care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Other
Intervention Name(s)
Bundle of comorbidities care
Intervention Description
Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge
Primary Outcome Measure Information:
Title
Hospital readmission
Description
Hospital or ICU readmission
Time Frame
1-year observation
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
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)
Time Frame
Measured at regular 3, 6 and 12 months visits following patient's hospital discharge
Title
Cost-effectiveness
Description
Costs related to unplanned emergency visits and hospital length of stay following readmission
Time Frame
1-year observation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Adler, MD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Geneva University Hospitals
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Integrated Care of Co-morbidities vs Standard Care After AHRF in the Intensive Care Unit
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