NCT06230497

Brief Summary

Cardiac output (CO) monitoring is of primary importance in high-risk surgery and critically ill patients. Intermittent thermodilution (ThD) by means of a pulmonary artery catheter (PAC) was invasiveness, the occurrence of complications, and inability to estimate CO on a beat-by-beat basis may explain the reduction in routine use. Echocardiography is now widely used. However, a poor acoustic window, inaccurate diameter calculations, and difficulty maintaining the angle of insonation and blood flow within the recommended values may lead to inaccuracy in CO estimation.Pulse contour methods (PCMs) are commonly used as they seem to fulfill most of the characteristics of an "ideal" hemodynamic monitoring system. Mostcare can continuously and real-time monitor important circulatory indicators such as cardiac output, peripheral vascular resistance index (SVRI), cardiovascular impedance (Ztot), cardiac cycle efficiency (CCE), and maximum pressure gradient (dp/dt MAX). It may help identify the causes of difficulty in weaning patients from ventilators after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 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

First Submitted

Initial submission to the registry

January 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

January 14, 2025

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

January 17, 2024

Last Update Submit

January 12, 2025

Conditions

Keywords

Post-cardiac SurgeryVentilator weaningMostcareressure recording analytical method

Outcome Measures

Primary Outcomes (1)

  • The Cardiac Cycle Efficiency (CCE)(unit)

    The Cardiac Cycle Efficiency (CCE) parameter provided by Mostcare is a comprehensive index of cardiac function that takes into account the mechanical and geometric properties of the heart. It integrates the changes in pressure and volume throughout the cardiac cycle to provide a single value that reflects the heart's efficiency. CCE is computed as CCE= Wsys/Wbeat\*K(t), where Wsys is the power function from the systolic pressure wave, Wbeat is the power function from the entire cardiac cycle pressure wave, and K(t) is the ratio of mean pressure expected over mean pressure measured.

    Day1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to the ICU after cardiac surgery and mechanically ventilated for more than 24 hours

You may qualify if:

  • Patients admitted to the ICU after cardiac surgery
  • mechanically ventilated for more than 24 hours

You may not qualify if:

  • the presence of pathologies that could affect the quality and reliability of the arterial pulse transmission (aortic valve diseases, aortic aneurysm or dissection, thoracic outlet syndrome);
  • arrhythmias;
  • hemodynamic instability;
  • age less than 18 years or more than 80 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine of pekin union medical college hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

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

Study Record Dates

First Submitted

January 17, 2024

First Posted

January 30, 2024

Study Start

May 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 10, 2024

Last Updated

January 14, 2025

Record last verified: 2024-03

Locations