Prospective Evaluation of Electrical Cardiometry for Hemodynamic Monitoring in COPD Patients Admitted to the Respiratory Intensive Care Unit

NCT ID: NCT07208578

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2027-11-30

Brief Summary

This study investigates the reliability and clinical usefulness of non-invasive electrical cardiometry (ICON® device) in monitoring hemodynamic changes in COPD patients admitted to the respiratory intensive care unit (RICU).

Detailed Description

hemodynamic monitoring is critical in critically ill patients, especially those with COPD experiencing acute respiratory failure. Traditional invasive methods such as pulmonary artery catheterization are accurate but carry procedural risks. The ICON® device enables real-time, continuous, non-invasive assessment of parameters like cardiac output, stroke volume, systemic vascular resistance, and thoracic fluid content using thoracic bioimpedance. This prospective observational study will assess its reliability against clinical outcomes and evaluate the influence of different ventilation strategies (invasive, non-invasive, no ventilation) on hemodynamic changes. Data will be collected serially throughout ICU stay to determine ICON's contribution to optimizing patient management and risk stratification.

Conditions

Non-invasive Electrical Cardiometry

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Invasive Mechanical Ventilation Arm

COPD patients requiring intubation and invasive ventilation support. Hemodynamics will be continuously monitored using ICON to evaluate changes under invasive ventilation physiology.

No interventions assigned to this group

Non Invasive Mechanical Ventilation Arm

COPD patients managed with NIV (e.g., BiPAP/CPAP). The arm will assess ICON's ability to track hemodynamic responses to positive pressure without intubation.

No interventions assigned to this group

No Mechanical Ventilation Arm

COPD patients receiving supplemental oxygen therapy or room air only. This group serves as a baseline to study hemodynamic changes without ventilatory support.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years

Admission to RICU with COPD or COPD-related acute respiratory failure

Informed consent provided by patient or legal representative

Exclusion Criteria

• patients <18 years

Pregnant women

Injuries, burns, or skin conditions preventing electrode placement

Patients with uncontrolled seizures

Patients needing electrical DC shock

Refusal or withdrawal of informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yousef Tharwat Geris Qrqar

resident at the Chest Diseases and Tuberculosis Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Non-invasive Hemodynamic

Identifier Type: -

Identifier Source: org_study_id