- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240104
Monitoring of Heart to Guide Myocardial Injury Patients to Wean From Ventilation
A Randomized Controlled Study on Continuous Monitoring of Cardiac Index Variability to Guide Patients With Perioperative Myocardial Injury to Wean From Mechanical Ventilation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shu Li, doctor
- Phone Number: +86 010 88324480
- Email: lishu2401@163.com
Study Locations
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-
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Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Zheng Liu
- Phone Number: +86 010 88325294
- Email: rmkyc@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CI group
the cardiac index (CI) is continuously monitored during the weaning process
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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.
|
No Intervention: control group
No intervention measures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weaning success rate
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in-ICU mortality
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
28 day mortality
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
The incidence of ventilator-associated pneumonia
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
length of stay in ICU
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Investigators
- Study Chair: Shu Li, Peking University People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDL2023-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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