Cardio-circulatory and Respiratory Monitoring for Prediction of Outcome in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide, often necessitating invasive mechanical ventilation (MV) during acute exacerbations. Weaning these patients from MV is a critical juncture in their care, as prolonged ventilation is associated with increased complications, including ventilator-associated pneumonia, diaphragmatic dysfunction, and higher healthcare costs. Traditional weaning indices, such as the Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP), and the Integrative Weaning Index (IWI), New Integrative Weaning Index (NIWI) have been employed to predict weaning outcomes. However, their predictive accuracy in COPD patients is variable, often due to the heterogeneous nature of the disease and the presence of comorbidities. Recent advancements have introduced non-invasive hemodynamic monitoring tools, such as the ICON® (Electrical Cardiometry), which measures parameters like cardiac output, stroke volume, and thoracic fluid content. These parameters may offer additional insights into a patient's readiness for weaning by providing real-time data on cardiovascular and fluid status, which are crucial in the weaning process. There is a scarcity of data comparing the predictive value of ICON parameters with traditional weaning indices in COPD patients. Understanding whether ICON-derived metrics can enhance weaning predictions and lead to more individualized and effective weaning strategies, reducing the duration of MV and improving patient outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All COPD patients who are mechanically ventilated for more than 48 h due to acute exacerbation and fulfilling weaning criteria will be included in the study.

Disqualifiers

Patients younger than 18 years old.

Patients with pneumothorax, pleural, or pericardial effusion.

Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.

Trial population

location: Assiut University Hospital Respiratory Intensive Care unit Population: All COPD patients admitted to Assiut University Hospital Respiratory Intensive Care unit, willingly sign informed consent, match the inclusion criteria and don't have a feature listed in the exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

104 Participants
are grouped into 2 trial groups
Group A: Success
Group B: Failed

Trial outcomes

Primary outcomes

1

Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients.

Assess the accuracy of the non-invasive hemodynamic parameters (Cardiac index, Thoracic fluid content, contractility, contractility index, systemic vascular resistance) using Electric Cardiometry device ICON® to predict the outcome of the weaning trial in mechanically ventilated COPD patients.

Time frame
2 Years

Secondary outcomes

1

Evaluate respiratory indices (RSBI, IWI, MIWI) as predictors of weaning outcome in mechanically ventilated COPD patients

Assess the accuracy of currently used respiratory indices (RSBI, IWI, MIWI) in the prediction of the outcome of weaning trial. These indices are currently used widely to predict the success or failure of weaning; However, there as still no consensus on a universal parameter and cut-off point.

Time frame
2 years

Other outcomes

Sponsors and contacts

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