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

NCT07109206 | Not Yet Recruiting

• 1 other identifier: KarimPhD1
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intensive-care, COPD, ICON, Weaning

Outcome Measures

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.

  2 Years

Secondary Outcomes (1)

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

  2 years

Study Arms (2)

Success

Cases with successful weaning and extubation from mechanical ventilation

Failed

Group with failed weaning trial

Eligibility Criteria

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

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Medical School.

Asyut, Egypt, 71111, Egypt

Location

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karim Sleem, Master's Degree

  Assiut University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim Osama Sleem, Masters Degree of Medicine

CONTACT

+201008955986; karimosama81@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: August 7, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 20, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

EG (1)