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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07109206
Enrollment
104
Registered
2025-08-07
Start date
2025-08-30
Completion date
2028-07-20
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometry, COPD (Chronic Obstructive Pulmonary Disease), Weaning Invasive Mechanical Ventilation

Keywords

Intensive-care, COPD, ICON, Weaning

Brief summary

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

1. Patients younger than 18 years old. 2. Patients with pneumothorax, pleural, or pericardial effusion. 3. Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients.2 YearsAssess 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.

Secondary

MeasureTime frameDescription
Evaluate respiratory indices (RSBI, IWI, MIWI) as predictors of weaning outcome in mechanically ventilated COPD patients2 yearsAssess 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.

Countries

Egypt

Contacts

Primary ContactKarim Osama Sleem, Masters Degree of Medicine
karimosama81@gmail.com+201008955986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026