Cardiac Output, LowNCT06198621
Hemodynamic Parameters Assessment; Invasive Versus Noninvasive
An observational study of Cardiac Output, Low, run by Assiut University.
Trial summary
The study aims at evaluating effectiveness of noninvasive cardiometry in assessment of cardiac parameters in critically ill patients in respiratory ICU in comparison to invasive methods as indirect fick's and thermodilution methods using pulmonary artery catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- cardiometry
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Jun 2025
- 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: Respiratory ICU patients
Who may be able to join
- Patients who are 18 years old or more.
- Critically ill patient in respiratory ICU unit with or without hemodynamic instability.
Who cannot join
- Presence of active infection at the site of insertion of PCA.
- Presence of coagulopathy or severe thrombocytopenia.
- Presence of cardiac arrhythmia or left bundle branch block.
- Newly inserted pacemaker of the heart.
- Lack of consent.
About this study
Official title: Noninvasive Versus Invasive Methods in Assessment of Hemodynamic Parameters in Respiratory ICU Patients
The study aims at evaluating effectiveness of noninvasive cardiometry in assessment of cardiac parameters in critically ill patients in respiratory ICU in comparison to invasive methods as indirect fick's and thermodilution methods using pulmonary artery catheter.
Read the detailed description
Patients and methods
- Study setting The study will be conducted in Assiut University Hospital, in respiratory intensive care unit.
- Study design This study is a cross-sectional study
C.Methods
Firstly, invasive methods:
The Fick method is a "gold standard" measurement of cardiac output. This method is based on the principle described by Adolfo Fick in 1870, according to which the total uptake or release of a substance by an organ is the product of the blood flow through the organ and the arteriovenous concentration difference of the substance.
The oxygen uptake in the lungs is the product of the blood flow through the lungs and the arteriovenous oxygen content difference. Therefore, the cardiac output, CO, can be calculated using the equation:
CO= VO2/(CaO2-CvO2)
Where VO2 is the oxygen consumption by the lungs and (CaO2-CvO2) is the arteriovenous difference in oxygen. VO2 can be compensated for, based on calculated body surface area (BAS), using equation of = 125 × BSA. The arteriovenous difference is computed by receiving samples of arterial oxygen saturation through arterial blood gases, and mixed venous oxygen saturation through receiving blood from the pulmonary artery using PAC.
Another method is thermodilution, this method uses a special thermistor tipped catheter (Swan-Ganz catheter) inserted from a central vein into the pulmonary artery. A normal saline (temperature 0 degrees Celsius) is injected into the right atrium from a proximal catheter port. This solution causes a decrease in blood temperature, which is measured by a thermistor placed in the pulmonary artery catheter. The pulmonary artery catheter is attached to the cardiac output computer, which displays a curve and calculates output and derived indices automatically.
Secondly, noninvasive methods Electrical cardiometry will be attached to patient using four electrodes. Two electrodes will be on the left side of the neck and the two other electrodes on the left side of the chest opposite to the xiphoid process at the mid-axillary line.
This allow for the continuous measurement of the changes of electrical conductivity within the thorax. By sending low amplitude, high frequency electrical current through the thorax, the resistance that the current faces (due to several factors) is measured. Through advanced filtering techniques, Electrical Cardiometry (EC) is able to isolate the changes in conductivity created by the circulatory system.
This can determine the stroke volume, cardiac output and other hemodynamic indcies.
Another noninvasive method which is used in assessment of cardiac parameters is echocardiography.
- Action plan and outcomes
- All patients' data regarding age, gender, sex and essential diagnosis will be taken.
- Patients' vital signs especially blood pressure and heart rate.
- Hemoglobin level will be acquired for all patients.
- Arterial blood gases especially arterial oxygen saturation.
- Venous blood gases obtained through Swan Ganz catheter.
- Patients' body surface area using patient height and weight will be obtained
- All patients will have cardiac parameters assessment using electrical cardiometry.
- Echocardiography will be recorded for patients.
- Conditions
- Cardiac Output, Low
- Being tested
- cardiometry
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiometryDevice
Also called pulmonary artery catheter (swan ganz)
cardiometry is noninvasive method, while swan ganz is invasive method in hemodynamic parameters assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of noninvasive cardiometry
To know the effectiveness of noninvasive cardiometry - icon cardiometry - in determining patient's cardiac output and other hemodynamic parameters as stroke volume and cardiac index in comparison to invasive methods using swan ganz catheter as ficks method and thermodilution method. This will be done through computing sensitivity, specificity and accuracy of noninvasive cardiometry.
Measured: 1 year
Secondary outcomes (1)
Abnormal cardiac output in critically ill patients
To know the prevalence of cardiac output abnormalities in critically ill patients in respiratory ICU.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Reda, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198621
- Sponsor's protocol ID
- cardiometry for hemodynamics
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hett DA, Jonas MM. Non-invasive cardiac output monitoring. Intensive Crit Care Nurs. 2004 Apr;20(2):103-8. doi: 10.1016/j.iccn.2004.01.002.
PubMed 15072778Rodriguez Ziccardi M, Khalid N. Pulmonary Artery Catheterization. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482170/
PubMed 29489212Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.
PubMed 20218415Siebenmann C, Rasmussen P, Sorensen H, Zaar M, Hvidtfeldt M, Pichon A, Secher NH, Lundby C. Cardiac output during exercise: a comparison of four methods. Scand J Med Sci Sports. 2015 Feb;25(1):e20-7. doi: 10.1111/sms.12201. Epub 2014 Mar 20.
PubMed 24646113
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Versus Invasive Methods in Assessment of Hemodynamic Parameters in Respiratory ICU Patients
- ClinicalTrials.gov ID
- NCT06198621
- Acronym / sponsor ID
- cardiometry for hemodynamics
- Conditions
- Cardiac Output, Low
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 10 Jan 2024 (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.
The study aims at evaluating effectiveness of noninvasive cardiometry in assessment of cardiac parameters in critically ill patients in respiratory ICU in comparison to invasive methods as indirect fick's and thermodilution methods using pulmonary artery catheter.
Detailed description
Patients and methods
- Study setting The study will be conducted in Assiut University Hospital, in respiratory intensive care unit.
- Study design This study is a cross-sectional study
C.Methods
Firstly, invasive methods:
The Fick method is a "gold standard" measurement of cardiac output. This method is based on the principle described by Adolfo Fick in 1870, according to which the total uptake or release of a substance by an organ is the product of the blood flow through the organ and the arteriovenous concentration difference of the substance.
The oxygen uptake in the lungs is the product of the blood flow through the lungs and the arteriovenous oxygen content difference. Therefore, the cardiac output, CO, can be calculated using the equation:
CO= VO2/(CaO2-CvO2)
Where VO2 is the oxygen consumption by the lungs and (CaO2-CvO2) is the arteriovenous difference in oxygen. VO2 can be compensated for, based on calculated body surface area (BAS), using equation of = 125 × BSA. The arteriovenous difference is computed by receiving samples of arterial oxygen saturation through arterial blood gases, and mixed venous oxygen saturation through receiving blood from the pulmonary artery using PAC.
Another method is thermodilution, this method uses a special thermistor tipped catheter (Swan-Ganz catheter) inserted from a central vein into the pulmonary artery. A normal saline (temperature 0 degrees Celsius) is injected into the right atrium from a proximal catheter port. This solution causes a decrease in blood temperature, which is measured by a thermistor placed in the pulmonary artery catheter. The pulmonary artery catheter is attached to the cardiac output computer, which displays a curve and calculates output and derived indices automatically.
Secondly, noninvasive methods Electrical cardiometry will be attached to patient using four electrodes. Two electrodes will be on the left side of the neck and the two other electrodes on the left side of the chest opposite to the xiphoid process at the mid-axillary line.
This allow for the continuous measurement of the changes of electrical conductivity within the thorax. By sending low amplitude, high frequency electrical current through the thorax, the resistance that the current faces (due to several factors) is measured. Through advanced filtering techniques, Electrical Cardiometry (EC) is able to isolate the changes in conductivity created by the circulatory system.
This can determine the stroke volume, cardiac output and other hemodynamic indcies.
Another noninvasive method which is used in assessment of cardiac parameters is echocardiography.
- Action plan and outcomes
- All patients' data regarding age, gender, sex and essential diagnosis will be taken.
- Patients' vital signs especially blood pressure and heart rate.
- Hemoglobin level will be acquired for all patients.
- Arterial blood gases especially arterial oxygen saturation.
- Venous blood gases obtained through Swan Ganz catheter.
- Patients' body surface area using patient height and weight will be obtained
- All patients will have cardiac parameters assessment using electrical cardiometry.
- Echocardiography will be recorded for patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Respiratory ICU patients
Key inclusion criteria (2 listed)
- Patients who are 18 years old or more.
- Critically ill patient in respiratory ICU unit with or without hemodynamic instability.
Key exclusion criteria (5 listed)
- Presence of active infection at the site of insertion of PCA.
- Presence of coagulopathy or severe thrombocytopenia.
- Presence of cardiac arrhythmia or left bundle branch block.
- Newly inserted pacemaker of the heart.
- Lack of consent.
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 |
|---|---|---|
| cardiometryAlso: pulmonary artery catheter (swan ganz)cardiometry is noninvasive method, while swan ganz is invasive method in hemodynamic parameters assessment | Device | – |
Primary outcome
Effectiveness of noninvasive cardiometry
Time frame: 1 year
To know the effectiveness of noninvasive cardiometry - icon cardiometry - in determining patient's cardiac output and other hemodynamic parameters as stroke volume and cardiac index in comparison to invasive methods using swan ganz catheter as ficks method and thermodilution method. This will be done through computing sensitivity, specificity and accuracy of noninvasive cardiometry.
1 secondary outcome
Abnormal cardiac output in critically ill patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 15072778Hett DA, Jonas MM. Non-invasive cardiac output monitoring. Intensive Crit Care Nurs. 2004 Apr;20(2):103-8. doi: 10.1016/j.iccn.2004.01.002.
- Background: PubMed 29489212Rodriguez Ziccardi M, Khalid N. Pulmonary Artery Catheterization. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482170/
- Background: PubMed 20218415Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.
- Background: PubMed 24646113Siebenmann C, Rasmussen P, Sorensen H, Zaar M, Hvidtfeldt M, Pichon A, Secher NH, Lundby C. Cardiac output during exercise: a comparison of four methods. Scand J Med Sci Sports. 2015 Feb;25(1):e20-7. doi: 10.1111/sms.12201. Epub 2014 Mar 20.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Cardiac Output, Low, 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 2 inclusion and 5 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 10 Jan 2024. 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?
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?
Effectiveness of noninvasive cardiometry (time frame: 1 year). 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 NCT06198621, which also lists 4 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 10 Jan 2024.