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

NCT04650412 — Not applicable, Terminated, 188 participants, CTU

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

Registry	NCT04650412, acronym TMIRA
Status	Terminated - delayed recruitment and lack of refinancing
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	188 (Actual)
Sponsor	CTU (Other); collaborators: Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped
Conditions	Acute Hypercapnic Respiratory Failure
Interventions	Bundle of comorbidities care (Other)
Dates	start 2018-05-28, primary completion 2022-07-31, completion 2022-07-31, first posted 2020-12-02, last updated 2023-05-12
Locations	3 sites in France, Switzerland

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Experimental	Other: Bundle of comorbidities care	Bundle of comorbidities care
Control	No intervention		Standard care

Bundle of comorbidities care (Other): Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge

+Outcome measures

Primary outcomes

Hospital readmission [1-year observation]: Hospital or ICU readmission

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (3)

Facility	City	Country
Centre Hospitalier Universitaire Grenoble Alpes	Grenoble	France
Geneva University Hospitals	Geneva	Switzerland
Centre Hospitalier Universitaire Vaudois	Lausanne	Switzerland

+Investigators

Dan Adler, MD, Principal investigator, University Hospital, Geneva

+Funding

NIH grants: 2016

My Notes

Public

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