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

NCT04650412 | Terminated

• 1 other identifier: 2016-01879
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 3

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.

Conditions

Acute Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Hospital readmission

  Hospital or ICU readmission

  1-year observation

Secondary Outcomes (2)

• Health Related Quality of Life

  Measured at regular 3, 6 and 12 months visits following patient's hospital discharge

• Cost-effectiveness

  1-year observation

Study Arms (2)

Intervention

EXPERIMENTAL

Bundle of comorbidities care

Other: Bundle of comorbidities care

Control

NO INTERVENTION

Standard care

Interventions

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent form signed
• Acute hypercapnic respiratory failure defined as PaCO2 \> 6.3 kPa requiring invasive or non-invasive mechanical ventilation in the ICU

You may not qualify if:

• 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

Sponsors & Collaborators

• CTU: lead
• Dan Adler is not working anymore at UGeneva, and nobody replaced him. This study is stopped: collaborator

Study Sites (3)

Centre Hospitalier Universitaire Grenoble Alpes

Grenoble, 38043, France

Location

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Dan Adler, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized controlled trial (bundle of comorbidity care vs standard care)

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 2, 2020
• Study Start: May 28, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CH (2)