Non-invasive Electrical CardiometryNCT07208578
Prospective Evaluation of Electrical Cardiometry for Hemodynamic Monitoring in COPD Patients Admitted to the Respiratory Intensive Care Unit
An observational study of Non-invasive Electrical Cardiometry, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-invasive Electrical Cardiometry
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2026to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients (≥18 years) admitted with a confirmed diagnosis of COPD or COPD-related acute respiratory failure requiring ICU admission. Patients may present with hypoxemia, hypercapnia, or both. Participants will include both male and female patients admitted for exacerbations or decompensation, receiving either invasive mechanical ventilation, non-invasive mechanical ventilation, or supplemental oxygen. Exclusions include patients with electrode placement limitations (e.g., skin injuries), seizure disorders, pregnancy, or those refusing consent.
Who may be able to join
- Age ≥ 18 years
- Admission to RICU with COPD or COPD-related acute respiratory failure
- Informed consent provided by patient or legal representative
Who cannot join
- 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
About this study
Official title: Non-invasive Hemodynamic Monitoring in COPD Patients Admitted to the Respiratory Intensive Care Unit: Reliability, Clinical Utility, and Ventilation-related Hemodynamic Changes
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).
Read the 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
- Keywords
- non-invasive electrical cardiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output (CO) measured by the electrical cardiometer (ICON®) in COPD patients admitted to the respiratory ICU.
The change in cardiac output values during the ICU stay as measured non-invasively by the ICON device, reflecting hemodynamic status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Jan 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive Electrical CardiometryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousef Tharwat Geris Qrqar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208578
- Sponsor's protocol ID
- Non-invasive Hemodynamic
- Status last verified
- Sep 2025
- First submitted
- 28 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Hemodynamic Monitoring in COPD Patients Admitted to the Respiratory Intensive Care Unit: Reliability, Clinical Utility, and Ventilation-related Hemodynamic Changes
- ClinicalTrials.gov ID
- NCT07208578
- Acronym / sponsor ID
- Non-invasive Hemodynamic
- Conditions
- Non-invasive Electrical Cardiometry
- Keywords
- non-invasive electrical cardiometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients (≥18 years) admitted with a confirmed diagnosis of COPD or COPD-related acute respiratory failure requiring ICU admission. Patients may present with hypoxemia, hypercapnia, or both. Participants will include both male and female patients admitted for exacerbations or decompensation, receiving either invasive mechanical ventilation, non-invasive mechanical ventilation, or supplemental oxygen. Exclusions include patients with electrode placement limitations (e.g., skin injuries), seizure disorders, pregnancy, or those refusing consent.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Admission to RICU with COPD or COPD-related acute respiratory failure
- Informed consent provided by patient or legal representative
Key exclusion criteria (6 listed)
- patients <18 years
- Pregnant women
- Injuries, burns, or skin conditions preventing electrode placement
- Patients with uncontrolled seizures
- Patients needing electrical DC shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac output (CO) measured by the electrical cardiometer (ICON®) in COPD patients admitted to the respiratory ICU.
Time frame: Baseline
The change in cardiac output values during the ICU stay as measured non-invasively by the ICON device, reflecting hemodynamic status.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Electrical Cardiometry, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (CO) measured by the electrical cardiometer (ICON®) in COPD patients admitted to the respiratory ICU. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.