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

A

Assiut University

Status

Not yet enrolling

Conditions

Non-invasive Electrical Cardiometry

Study type

Observational

Funder types

Other

Identifiers

NCT07208578
Non-invasive Hemodynamic

Details and patient eligibility

About

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).

Full 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.

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

96 participants in 3 patient groups

Invasive Mechanical Ventilation Arm
Description:
COPD patients requiring intubation and invasive ventilation support. Hemodynamics will be continuously monitored using ICON to evaluate changes under invasive ventilation physiology.
Non Invasive Mechanical Ventilation Arm
Description:
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 Mechanical Ventilation Arm
Description:
COPD patients receiving supplemental oxygen therapy or room air only. This group serves as a baseline to study hemodynamic changes without ventilatory support.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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