Hemodynamic Parameters Assessment; Invasive Versus Noninvasive

NCT ID: NCT06198621

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Output, Low

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cardiometry

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

pulmonary artery catheter (swan ganz)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dina Reda

Assistant lecturer in pulmonolgy department

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15072778 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 29489212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20218415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24646113 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

cardiometry for hemodynamics

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ultrasound-Guided BCV and IJV in ICU Patients
NCT07062068 NOT_YET_RECRUITING NA