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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
CTU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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