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Not yet recruitingNCT06198621Updated Jan 10, 2024

Hemodynamic Parameters Assessment; Invasive Versus Noninvasive

An observational study in Cardiac Output, Low, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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 the detailed description

Patients and methods

A. Study setting The study will be conducted in Assiut University Hospital, in respiratory intensive care unit.

B. 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.

D. Action plan and outcomes

  1. All patients' data regarding age, gender, sex and essential diagnosis will be taken.
  2. Patients' vital signs especially blood pressure and heart rate.
  3. Hemoglobin level will be acquired for all patients.
  4. Arterial blood gases especially arterial oxygen saturation.
  5. Venous blood gases obtained through Swan Ganz catheter.
  6. Patients' body surface area using patient height and weight will be obtained
  7. All patients will have cardiac parameters assessment using electrical cardiometry.
  8. Echocardiography will be recorded for patients.
02

Conditions studied

  • Cardiac Output, Low

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03

In context

Cardiac Output, Low

94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's planned enrollment of 75 is above the median of 60 across 45 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Respiratory ICU patients

Inclusion criteria

  1. Patients who are 18 years old or more.
  2. Critically ill patient in respiratory ICU unit with or without hemodynamic instability.

Exclusion criteria

Exclusion Criteria:

  1. Presence of active infection at the site of insertion of PCA.
  2. Presence of coagulopathy or severe thrombocytopenia.
  3. Presence of cardiac arrhythmia or left bundle branch block.
  4. Newly inserted pacemaker of the heart.
  5. Lack of consent.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75 participants (estimated)
Patient registry
No

Interventions

  • Devicecardiometry

    cardiometry is noninvasive method, while swan ganz is invasive method in hemodynamic parameters assessment

    Also known as: pulmonary artery catheter (swan ganz)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

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 15072778 ↗
  • Rodriguez Ziccardi M, Khalid N. Pulmonary Artery Catheterization. 2023 Aug 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482170/ PubMed 29489212 ↗
  • Evans 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 20218415 ↗
  • Siebenmann 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06198621
Lead sponsor
Assiut University
Responsible party
Dina Reda (Assistant lecturer in pulmonolgy department, Assiut University) — Principal investigator
First posted
Jan 10, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jan 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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