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CompletedNCT06230497Updated Jan 14, 2025

Correlation Analysis Between Mostcare Parameters and Spontaneous Breathing Trial in Patients After Cardiac Surgery

An observational study in Post-cardiac Surgery and Ventilator Weaning, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Peking Union Medical College Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

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) has been used as the reference method and to validate alternative monitoring systems. Its 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 in ICUs for the complete assessment of heart function, volume status, and CO measurement. Because it has been well accepted as a first-line diagnostic tool for circulatory failure, it has been proposed as an alternative for ThD to evaluate CO in selected patient populations . 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.Finally, training is of major importance.

Pulse contour methods (PCMs) are commonly used in operating rooms or ICUs 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.

This is a prospective observational study. Patients admitted to the ICU after cardiac surgery and mechanically ventilated for more than 24 hours were monitored for mostcare before attempting to withdraw from the ventilator, and assessment of systemic circulation and cardiac ultrasound was completed.

Patients were given an spontaneous breathing test(SBT) off the ventilator. Mostcare parameters were also recorded. If the SBT experiment was successful the endotracheal tube was removed, if it failed then mostcare monitoring and assessment of circulation and ultrasound were performed again after resumption of mechanical ventilation.

02

Conditions studied

  • Post-cardiac Surgery
  • Ventilator Weaning

Keywords

  • Post-cardiac Surgery
  • Ventilator weaning
  • Mostcare
  • ressure recording analytical method
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.

Of its 5 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 to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients admitted to the ICU after cardiac surgery
  2. mechanically ventilated for more than 24 hours

Exclusion criteria

Exclusion Criteria:

  1. 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);
  2. arrhythmias;
  3. hemodynamic instability;
  4. age less than 18 years or more than 80 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: Day1

07

Study locations

1 site
  • Department of Critical Care Medicine of pekin union medical college hospital
    Beijing, Beijing Municipality 100730, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06230497
Responsible party
Sponsor
First posted
Jan 30, 2024
Start date
May 1, 2024
Primary completion
Oct 1, 2024
Completion
Oct 10, 2024
Last update
Jan 14, 2025

Oversight

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

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