Non-invasive Hemodynamic MonitoringNCT06110013
Value of Non Invasive Hemodynamic Monitoring in Patients Admitted to Respiratory Intensive Care Unit
An observational study of Non-invasive Hemodynamic Monitoring, run by Assiut University.
Trial summary
This study aims to evaluate clinical application of electrical cardiometry EC in patients admitted to respiratory ICU. It will evaluate the reliability of EC in assessment of hemodynamic changes in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-invasive Hemodynamic Monitoring
- What is being tested?
- Electrical cardiometry
- Type of treatment
- Medical device
- How many people
- 177 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients admitted to respiratory intensive care unit (ICU)
Who may be able to join
- All patients admitted to respiratory intensive care unit (ICU) among both sexes Age >18 years Old.
Who cannot join
- Patients less than 18 years old .
- Pregnant women.
- Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
- those with uncontrollable fits.
- Patients who need electrical direct current (DC) shock.
- Patients who refuse to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to evaluate clinical application of electrical cardiometry EC in patients admitted to respiratory ICU. It will evaluate the reliability of EC in assessment of hemodynamic changes in these patients. It will estimate the effect of mechanical ventilation either invasive or non invasive hemodynamic parameters in patients admitted to ICU with respirator disorders
Read the detailed description
Mechanical ventilation MV is a life saving intervention in intensive care units. Access to lower airways is achieved either through tracheostomy or endotracheal intubation. More recently non invasive ventilation NIV techniques were introduced that do not require an endotracheal airway but using patient ventilator interfaces in the form of facial masks have been designed.
The haemodynamic consequences of MV are multiple and complex and may affect all the determinants of cardiac performance such as heart rate.preload.contractility .and afterload. These consequences affect both right and left ventricle and are also related to the biventricular interdependence .
Mechanically ventilated patients are considered Critically ill.and they are often hemodynamically unstable or at risk of becoming unstable owing to hypovolemia. cardiac dysfunction. or alterations of vasomotor function. leading to organ dysfunction.deterioration into multiorgan failure .and eventually death .Socardiopulmonary monitoring is crucial to ensure successful evaluation and management of these patients . With hemodynamic monitoring. The investigators aim to guide our medical management to prevent or treat organ failure and improve the outcomes of our patients. Therapeutic measures may include fluid resuscitation.vasopressors or inotropic agents .
Hemodynamic monitoring can be done by different techniques which ranges from invasive to less invasive and completely noninvasive methods to assess Cardiac output BP oxygen saturation. Some hemodynamic parameters are easy to be measured like blood pressure and heart rate but do not give a complete picture of a patient's hemodynamics .
Measuring CO and its components preload afterload and contractility will tell us if there is ongoing need for fluid resuscitation vasopressors or inotropic agents . It can be used as a diagnostic tool to determine the type of shock hypovolemic cardiogenic obstructive or distributive according to the hemodynamic profile .
Traditional invasive methods incorporate thermodilution which requires that a transvenous catheter pushed forward to the pulmonary artery PAC Swan Ganz catheter. Other invasive methods require an arterial line to measure the blood pressure signal waveform . Due to the invasiveness the associated risk invasive methods are usually employed at an advanced stage of illness .
Non invasive hemodynamic methods have less complications. Recent techniques advances led to continuous non invasive monitoring that allow for data obtaining at bedside of critically ill patients in ICU these advances help to monitor changes and allow for management before complications .
A portable Electro Cardiometer ICON Osypka Medical GmbH Berlin Germany is a Hand held Portable battery operated non invasive cardiometer for continuous measurement of different hemodynamic parameters stroke volume SV cardiac output CO contractility fluid status and oxygen status in neonate children or adults Applied to the patients through 4 ECG electrodes. It is based on the measurement of changes in thoracic impedance to an electrical current that is produced by fluctuations in thoracic blood volume with each cardiac cycle .
Newer generation Thoracic Electrical Bioimpedence methods have overcome some of the limitations that was present in old models by having faster signal processing better signal filters improved ECG triggering and respiratory filtering .
Up till now there is limited research about ICON device and it's reliability in monitoring hemodynamics specially in respiratory ICU patients.
- Conditions
- Non-invasive Hemodynamic Monitoring
- Being tested
- Electrical cardiometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical cardiometryDevice
Also called ICON
All included patients will be connected to Electrical cardiometry device. The electrodes will be placed over the bare skin of patients at the following sites:
- on the left neck below the ear B. directly superior to the midpoint of the left clavicle C. along the left mid-axillary line at the level of the xiphoid process D. two inches below the third electrode. High frequency signals pass through 2 acting electrodes, the other 2 measuring electrodes detect changes in bioimpedance resistance to allow continuous hemodynamic monitoring, then data will be analysed to give comprehensive picture of the hemodynamic circulatory system, allowing differential diagnosis for a patient management
| Study group | Role | What they receive |
|---|---|---|
| A | Patients on invasive mechanical ventilation Receives: Device: Electrical cardiometry | |
| B | Patients on Non invasive mechanical ventilation Receives: Device: Electrical cardiometry | |
| C | Patients Not on mechanical ventilation Receives: Device: Electrical cardiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of non invasive hemodynamic monitoring
Effectiveness of clinical application of non invasive hemodynamic monitoring using electrical cardiometer in patients admitted to respiratory intensive care unit
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-invasive Hemodynamic MonitoringStudies 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
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Sayed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110013
- Sponsor's protocol ID
- Hemodynamic monitoring
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.
PubMed 17492379Russell A, Rivers EP, Giri PC, Jaehne AK, Nguyen HB. A Physiologic Approach to Hemodynamic Monitoring and Optimizing Oxygen Delivery in Shock Resuscitation. J Clin Med. 2020 Jun 30;9(7):2052. doi: 10.3390/jcm9072052.
PubMed 32629778Nagel JH, Shyu LY, Reddy SP, Hurwitz BE, McCabe PM, Schneiderman N. New signal processing techniques for improved precision of noninvasive impedance cardiography. Ann Biomed Eng. 1989;17(5):517-34. doi: 10.1007/BF02368071.
PubMed 2610423
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Non Invasive Hemodynamic Monitoring in Patients Admitted to Respiratory Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06110013
- Acronym / sponsor ID
- Hemodynamic monitoring
- Conditions
- Non-invasive Hemodynamic Monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 31 Oct 2023 (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 aims to evaluate clinical application of electrical cardiometry EC in patients admitted to respiratory ICU. It will evaluate the reliability of EC in assessment of hemodynamic changes in these patients. It will estimate the effect of mechanical ventilation either invasive or non invasive hemodynamic parameters in patients admitted to ICU with respirator disorders
Detailed description
Mechanical ventilation MV is a life saving intervention in intensive care units. Access to lower airways is achieved either through tracheostomy or endotracheal intubation. More recently non invasive ventilation NIV techniques were introduced that do not require an endotracheal airway but using patient ventilator interfaces in the form of facial masks have been designed.
The haemodynamic consequences of MV are multiple and complex and may affect all the determinants of cardiac performance such as heart rate.preload.contractility .and afterload. These consequences affect both right and left ventricle and are also related to the biventricular interdependence .
Mechanically ventilated patients are considered Critically ill.and they are often hemodynamically unstable or at risk of becoming unstable owing to hypovolemia. cardiac dysfunction. or alterations of vasomotor function. leading to organ dysfunction.deterioration into multiorgan failure .and eventually death .Socardiopulmonary monitoring is crucial to ensure successful evaluation and management of these patients . With hemodynamic monitoring. The investigators aim to guide our medical management to prevent or treat organ failure and improve the outcomes of our patients. Therapeutic measures may include fluid resuscitation.vasopressors or inotropic agents .
Hemodynamic monitoring can be done by different techniques which ranges from invasive to less invasive and completely noninvasive methods to assess Cardiac output BP oxygen saturation. Some hemodynamic parameters are easy to be measured like blood pressure and heart rate but do not give a complete picture of a patient's hemodynamics .
Measuring CO and its components preload afterload and contractility will tell us if there is ongoing need for fluid resuscitation vasopressors or inotropic agents . It can be used as a diagnostic tool to determine the type of shock hypovolemic cardiogenic obstructive or distributive according to the hemodynamic profile .
Traditional invasive methods incorporate thermodilution which requires that a transvenous catheter pushed forward to the pulmonary artery PAC Swan Ganz catheter. Other invasive methods require an arterial line to measure the blood pressure signal waveform . Due to the invasiveness the associated risk invasive methods are usually employed at an advanced stage of illness .
Non invasive hemodynamic methods have less complications. Recent techniques advances led to continuous non invasive monitoring that allow for data obtaining at bedside of critically ill patients in ICU these advances help to monitor changes and allow for management before complications .
A portable Electro Cardiometer ICON Osypka Medical GmbH Berlin Germany is a Hand held Portable battery operated non invasive cardiometer for continuous measurement of different hemodynamic parameters stroke volume SV cardiac output CO contractility fluid status and oxygen status in neonate children or adults Applied to the patients through 4 ECG electrodes. It is based on the measurement of changes in thoracic impedance to an electrical current that is produced by fluctuations in thoracic blood volume with each cardiac cycle .
Newer generation Thoracic Electrical Bioimpedence methods have overcome some of the limitations that was present in old models by having faster signal processing better signal filters improved ECG triggering and respiratory filtering .
Up till now there is limited research about ICON device and it's reliability in monitoring hemodynamics specially in respiratory ICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Electrical cardiometryPatients on invasive mechanical ventilation |
| B | – | Device: Electrical cardiometryPatients on Non invasive mechanical ventilation |
| C | – | Device: Electrical cardiometryPatients Not on mechanical ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to respiratory intensive care unit (ICU)
Key inclusion criteria (1 listed)
- All patients admitted to respiratory intensive care unit (ICU) among both sexes Age >18 years Old.
Key exclusion criteria (6 listed)
- Patients less than 18 years old .
- Pregnant women.
- Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes will be also excluded from the study.
- those with uncontrollable fits.
- Patients who need electrical direct current (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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical cardiometryAlso: ICONAll included patients will be connected to Electrical cardiometry device. The electrodes will be placed over the bare skin of patients at the following sites: A. on the left neck below the ear B. directly superior to the midpoint of the left clavicle C. along the left mid-axillary line at the level of the xiphoid process D. two inches below the third electrode. High frequency signals pass through 2 acting electrodes, the other 2 measuring electrodes detect changes in bioimpedance resistance to allow continuous hemodynamic monitoring, then data will be analysed to give comprehensive picture of the hemodynamic circulatory system, allowing differential diagnosis for a patient management | Device | A, B, C |
Primary outcome
Effectiveness of non invasive hemodynamic monitoring
Time frame: Baseline
Effectiveness of clinical application of non invasive hemodynamic monitoring using electrical cardiometer in patients admitted to respiratory intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Results publication: PubMed 17492379Masip J. Non-invasive ventilation. Heart Fail Rev. 2007 Jun;12(2):119-24. doi: 10.1007/s10741-007-9012-7.
- Results publication: PubMed 32629778Russell A, Rivers EP, Giri PC, Jaehne AK, Nguyen HB. A Physiologic Approach to Hemodynamic Monitoring and Optimizing Oxygen Delivery in Shock Resuscitation. J Clin Med. 2020 Jun 30;9(7):2052. doi: 10.3390/jcm9072052.
- Results publication: PubMed 2610423Nagel JH, Shyu LY, Reddy SP, Hurwitz BE, McCabe PM, Schneiderman N. New signal processing techniques for improved precision of noninvasive impedance cardiography. Ann Biomed Eng. 1989;17(5):517-34. doi: 10.1007/BF02368071.
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-invasive Hemodynamic Monitoring, 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 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma S Ahmed (0201126921373, fatmasayed389@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of non invasive hemodynamic monitoring (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110013, which also lists 3 linked publications.
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 31 Oct 2023.