Myocardial Ischaemia During SurgeryNCT06240104
Monitoring of Heart to Guide Myocardial Injury Patients to Wean From Ventilation
A study testing cardiac output index monitor in people with Myocardial Ischaemia During Surgery, run by Peking University People's Hospital at 1 site in China.
Trial summary
The goal of this prospective randomized controlled clinical trail is to explore the value of integrating continuous cardiac index variability indicators with existing weaning standards to guide perioperative myocardial injury patients weaning. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Ischaemia During Surgery
- What is being tested?
- cardiac output index monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Perioperative myocardial injury patients
- Age>18 years;
- Acute Physiology and Chronic Health Evaluation II (APACHEII)>8 ;
- The weaning process has not yet started after surgery;
- Expected postoperative cumulative mechanical ventilation time>24 hours.
Who cannot join
- Pregnancy or childbirth less than 42 days;
- Patients and their families are unable to cooperate with treatment;
- The cumulative actual mechanical ventilation time after surgery is ≤ 24 hours;
- Interruption of mechanical ventilation treatment due to death or other reasons before entering the weaning process;
- Patients who retain artificial airways after weaning;
- Patients who plan to start non-invasive mechanical ventilation treatment immediately after weaning.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Zheng Liu, +86 010 88325294, rmkyc@163.com
About this study
Official title: A Randomized Controlled Study on Continuous Monitoring of Cardiac Index Variability to Guide Patients With Perioperative Myocardial Injury to Wean From Mechanical Ventilation
The goal of this prospective randomized controlled clinical trail is to explore the value of integrating continuous cardiac index variability indicators with existing weaning standards to guide perioperative myocardial injury patients weaning. The main question it aims to answer is: whether the introduction of new indicators for weaning standards can improve the success rate of weaning. Treatment that'll be given to participants is: the cardiac index (CI) is continuously monitored from 15-30 minutes prior to the start of the weaning from ventilation. Participants who increase their CI by more than 30% can have their tracheal intubation removed. Researchers will compare the weaning success rate of CI group and control group.
Read the detailed description
In this study, investigator'll recruit participants of perioperative myocardial injury as the research objects, the continuous cardiac index variability index was added to the current traditional weaning standard to form a new weaning standard. In this prospective, randomized, and controlled study, the impact of the new weaning standard and the traditional weaning standard on weaning failure rate was compared. Whether the new weaning standard is superior to ordinary weaning standards is evaluated in terms of participants prognosis, incidence of complications, and medical resource consumption.
Quality assurance plan that addresses data validation and registry procedures: Two researchers who have received unified training record and register participant data separately, and a third researcher conducts weekly data checks to compare data entered into the registry against predefined rules for range. The source data will be verified to assess the accuracy, completeness of registry data by comparing the data to medical records and paper or electronic case report forms.
Standard Operating Procedures to address participant recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be formulated before recruit.
The estimation of sample size is based on testing that the new weaning standard is superior to traditional standards in improving weaning success rate. According to previous reports and our previous study data, the sample size was calculated using PASS 11.0 software. The results showed that 91 cases were needed in each group. Considering a 5% dropout rate, 100 participants were included in each group for a total of 200 participants.
Plan for missing data: Investigator will verify the data monthly and recruit sufficient participants according to the research protocol and statistical requirements.
Statistical analysis plan:
- Use SAS 10.0 statistical software for statistical analysis. Quantitative data is represented by mean, standard deviation, median and interquartile range, while count data is represented by absolute frequency and composition ratio.
- The comparison of weaning success rates for primary study endpoints was conducted using the confidence interval method. Calculate the one-sided 95% confidence interval for the difference in success rates between the new offline standard group and the traditional offline standard group, if this interval is greater than δ Value, it can be considered that the new offline standard is superior to the traditional offline standard.
- Secondary study endpoints: basic demographic characteristics and clinical indicators, postoperative mechanical ventilation time, ICU stay, hospital stay, and incidence of ventilator-associated pneumonia. Student t-tests and rank sum tests were used for inter group comparison of quantitative data; The inter group comparison of counting data adopts kapa Inspection. All tests are bilateral tests with significance levels α = 0.05.
- The patient's survival status was described using Kaplan Meier survival curves, and intergroup differences were tested using the Breslow method.
- Conditions
- Myocardial Ischaemia During Surgery
- Being tested
- cardiac output index monitor
- Keywords
- cardiac index variability, wean from mechanical ventilation, perioperative myocardial injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac output index monitorDiagnostic test
During the spontaneous breathing test phase, the cardiac index (CI) is continuously monitored from 15-30 minutes prior to the start of the test. Patients who have successfully completed the spontaneous breathing test and increased their CI by more than 30% and meet ordinary weaning indications can have their tracheal intubation removed.
| Study group | Role | What they receive |
|---|---|---|
| CI group | Experimental | the cardiac index (CI) is continuously monitored during the weaning process Receives: Diagnostic Test: cardiac output index monitor |
| control group | No intervention | No intervention measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning success rate
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
in-ICU mortality
Measured: through study completion, an average of 1 year
28 day mortality
Measured: through study completion, an average of 1 year
The incidence of ventilator-associated pneumonia
Measured: through study completion, an average of 1 year
length of stay in ICU
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start19 Feb 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Ischaemia During SurgeryStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shu, Peking University People's Hospital
- Investigators
- Shu Li, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240104
- Sponsor's protocol ID
- RDL2023-09
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Continuous Monitoring of Cardiac Index Variability to Guide Patients With Perioperative Myocardial Injury to Wean From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT06240104
- Acronym / sponsor ID
- RDL2023-09
- Conditions
- Myocardial Ischaemia During Surgery
- Keywords
- cardiac index variability, wean from mechanical ventilation, perioperative myocardial injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Feb 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.
The goal of this prospective randomized controlled clinical trail is to explore the value of integrating continuous cardiac index variability indicators with existing weaning standards to guide perioperative myocardial injury patients weaning. The main question it aims to answer is: whether the introduction of new indicators for weaning standards can improve the success rate of weaning. Treatment that'll be given to participants is: the cardiac index (CI) is continuously monitored from 15-30 minutes prior to the start of the weaning from ventilation. Participants who increase their CI by more than 30% can have their tracheal intubation removed. Researchers will compare the weaning success rate of CI group and control group.
Detailed description
In this study, investigator'll recruit participants of perioperative myocardial injury as the research objects, the continuous cardiac index variability index was added to the current traditional weaning standard to form a new weaning standard. In this prospective, randomized, and controlled study, the impact of the new weaning standard and the traditional weaning standard on weaning failure rate was compared. Whether the new weaning standard is superior to ordinary weaning standards is evaluated in terms of participants prognosis, incidence of complications, and medical resource consumption.
Quality assurance plan that addresses data validation and registry procedures: Two researchers who have received unified training record and register participant data separately, and a third researcher conducts weekly data checks to compare data entered into the registry against predefined rules for range. The source data will be verified to assess the accuracy, completeness of registry data by comparing the data to medical records and paper or electronic case report forms.
Standard Operating Procedures to address participant recruitment, data collection, data management, data analysis, reporting for adverse events, and change management will be formulated before recruit.
The estimation of sample size is based on testing that the new weaning standard is superior to traditional standards in improving weaning success rate. According to previous reports and our previous study data, the sample size was calculated using PASS 11.0 software. The results showed that 91 cases were needed in each group. Considering a 5% dropout rate, 100 participants were included in each group for a total of 200 participants.
Plan for missing data: Investigator will verify the data monthly and recruit sufficient participants according to the research protocol and statistical requirements.
Statistical analysis plan:
- Use SAS 10.0 statistical software for statistical analysis. Quantitative data is represented by mean, standard deviation, median and interquartile range, while count data is represented by absolute frequency and composition ratio.
- The comparison of weaning success rates for primary study endpoints was conducted using the confidence interval method. Calculate the one-sided 95% confidence interval for the difference in success rates between the new offline standard group and the traditional offline standard group, if this interval is greater than δ Value, it can be considered that the new offline standard is superior to the traditional offline standard.
- Secondary study endpoints: basic demographic characteristics and clinical indicators, postoperative mechanical ventilation time, ICU stay, hospital stay, and incidence of ventilator-associated pneumonia. Student t-tests and rank sum tests were used for inter group comparison of quantitative data; The inter group comparison of counting data adopts kapa Inspection. All tests are bilateral tests with significance levels α = 0.05.
- The patient's survival status was described using Kaplan Meier survival curves, and intergroup differences were tested using the Breslow method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CI group | Experimental | Diagnostic Test: cardiac output index monitorthe cardiac index (CI) is continuously monitored during the weaning process |
| control group | No intervention | –No intervention measures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Perioperative myocardial injury patients
- Age>18 years;
- Acute Physiology and Chronic Health Evaluation II (APACHEII)>8 ;
- The weaning process has not yet started after surgery;
- Expected postoperative cumulative mechanical ventilation time>24 hours.
Key exclusion criteria (6 listed)
- Pregnancy or childbirth less than 42 days;
- Patients and their families are unable to cooperate with treatment;
- The cumulative actual mechanical ventilation time after surgery is ≤ 24 hours;
- Interruption of mechanical ventilation treatment due to death or other reasons before entering the weaning process;
- Patients who retain artificial airways after weaning;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac output index monitorDuring the spontaneous breathing test phase, the cardiac index (CI) is continuously monitored from 15-30 minutes prior to the start of the test. Patients who have successfully completed the spontaneous breathing test and increased their CI by more than 30% and meet ordinary weaning indications can have their tracheal intubation removed. | Diagnostic test | CI group |
Primary outcome
weaning success rate
Time frame: through study completion, an average of 1 year
4 secondary outcomes
in-ICU mortality
Time frame: through study completion, an average of 1 year
28 day mortality
Time frame: through study completion, an average of 1 year
The incidence of ventilator-associated pneumonia
Time frame: through study completion, an average of 1 year
length of stay in ICU
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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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.
Shu Li study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac output index monitor in people with Myocardial Ischaemia During Surgery, run by Peking University People's 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu Li, doctor (+86 010 88324480, lishu2401@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning success rate (time frame: through study completion, an average of 1 year). 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 2 Apr 2024.