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

CTU

Status: Terminated

Conditions: Acute Hypercapnic Respiratory Failure

Treatments: Other: Bundle of comorbidities care

Study type: Interventional

Funder types: Other

Identifiers

NCT04650412

2016-01879

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Intervention

Experimental group

Description:

Bundle of comorbidities care

Treatment:

Other: Bundle of comorbidities care

Control

No Intervention group

Description:

Standard care