NCT06198621

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

December 26, 2023

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

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.

    1 year

Secondary Outcomes (1)

  • Abnormal cardiac output in critically ill patients

    1 year

Interventions

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

Also known as: pulmonary artery catheter (swan ganz)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Respiratory ICU patients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15072778BACKGROUND
  • 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/

    PMID: 29489212BACKGROUND
  • 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.

    PMID: 20218415BACKGROUND
  • 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.

    PMID: 24646113BACKGROUND

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer in pulmonolgy department

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

January 10, 2024

Record last verified: 2024-01