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

Not Applicable

Terminated

• Conditions: Acute Hypercapnic Respiratory Failure
• Interventions: Other: Bundle of comorbidities care

• Registration Number: NCT04650412
• Lead Sponsor: CTU

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 188

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bundle of comorbidities care	Bundle of comorbidities care

Primary Outcome Measures

Name	Time	Method
Hospital readmission	1-year observation	Hospital or ICU readmission

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland

Centre Hospitalier Universitaire Grenoble Alpes; 🇫🇷 Grenoble, France