Post-cardiac SurgeryNCT06230497
Correlation Analysis Between Mostcare Parameters and Spontaneous Breathing Trial in Patients After Cardiac Surgery
An observational study of Post-cardiac Surgery and Ventilator Weaning, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-cardiac Surgery, Ventilator Weaning
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU after cardiac surgery and mechanically ventilated for more than 24 hours
Who may be able to join
- Patients admitted to the ICU after cardiac surgery
- mechanically ventilated for more than 24 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine of pekin union medical college hospital
Beijing, Beijing Municipality, 100730
About this study
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.
- Conditions
- Post-cardiac Surgery, Ventilator Weaning
- Keywords
- Post-cardiac Surgery, Ventilator weaning, Mostcare, ressure recording analytical method
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 May 2024
- Primary completion1 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230497
- Sponsor's protocol ID
- 216-4
- Status last verified
- Mar 2024
- First submitted
- 17 Jan 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between Mostcare Parameters and Spontaneous Breathing Trial in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06230497
- Acronym / sponsor ID
- 216-4
- Conditions
- Post-cardiac Surgery, Ventilator Weaning
- Keywords
- Post-cardiac Surgery, Ventilator weaning, Mostcare, ressure recording analytical method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU after cardiac surgery and mechanically ventilated for more than 24 hours
Key inclusion criteria (2 listed)
- Patients admitted to the ICU after cardiac surgery
- mechanically ventilated for more than 24 hours
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Cardiac Cycle Efficiency (CCE)(unit)
Time frame: Day1
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Post-cardiac Surgery
Active, not recruiting
Comparing Different Regional Blocks for Analgesia After Off-pump Cardiac Surgery
Analgesia
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Not yet recruitingPhase 3
SGB for Prevention of Postop A-Fib After Cardiac SurgeryTrial
Atrial Fibrillation, Postoperative Atrial Fibrillation
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cardiac Surgery and Ventilator Weaning, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Cardiac Cycle Efficiency (CCE)(unit) (time frame: Day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.