NCT02382120

Brief Summary

Cardiac output monitoring is mandatory in most surgical and critical care patients. Many techniques to assess cardiac output are invasive and/or have many limitations, contraindications and drawbacks. The measurement of cardiac output throughout the CO2 signal is an interesting option due to the simplicity and non-invasive nature of its calculation. The present study was designed to compare the cardiac output measurement using a capnodynamic formula versus the reference thermodilution method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 2, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2018

Completed
Last Updated

August 2, 2018

Status Verified

May 1, 2018

Enrollment Period

3.1 years

First QC Date

March 3, 2015

Last Update Submit

August 1, 2018

Conditions

Keywords

carbon dioxidecardiac outputventilationthermodilution

Outcome Measures

Primary Outcomes (1)

  • Accuracy and precision of capnodynamic to measure cardiac output

    Comparison between a reference method (thermodilution) with a new one (capnodynamics)

    8 months

Study Arms (1)

Patients undergoing cardiovascular surgery

Patients ASA 3-4 undergoing cardiac surgery.

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac surgical ASA II-III patients.

You may qualify if:

  • Written informed consent
  • Programmed cardiac surgeries
  • Surgeries with cardiopulmonary bypass

You may not qualify if:

  • Emergency surgeries.
  • Acute pulmonary diseases
  • Contraindication of femoral catheters.
  • Need of counter-pulsation baloon

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Related Publications (2)

  • Capek JM, Roy RJ. Noninvasive measurement of cardiac output using partial CO2 rebreathing. IEEE Trans Biomed Eng. 1988 Sep;35(9):653-61. doi: 10.1109/10.7266. No abstract available.

    PMID: 3139547BACKGROUND
  • Peyton PJ, Venkatesan Y, Hood SG, Junor P, May C. Noninvasive, automated and continuous cardiac output monitoring by pulmonary capnodynamics: breath-by-breath comparison with ultrasonic flow probe. Anesthesiology. 2006 Jul;105(1):72-80. doi: 10.1097/00000542-200607000-00015.

MeSH Terms

Conditions

Cardiovascular DiseasesRespiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gerardo Tusman, MD

    Hospital Privado de Comunidad de Mar del Plata

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 6, 2015

Study Start

March 2, 2015

Primary Completion

April 21, 2018

Study Completion

July 21, 2018

Last Updated

August 2, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations