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
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

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