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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CI group | Experimental | the cardiac index (CI) is continuously monitored during the weaning process |
|
| control group | No Intervention | No intervention measures |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac output index monitor | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| weaning success rate | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| in-ICU mortality | through study completion, an average of 1 year | |
| 28 day mortality | through study completion, an average of 1 year | |
| The incidence of ventilator-associated pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu Li, doctor | Contact | +86 010 88324480 | lishu2401@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shu Li | Peking University People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | 100044 | China |
Yes: There is a plan to make IPD and related data dictionaries available.
starting 1 year after publication, for 1 years
The project leader can be contacted to obtain the original data under reasonable and legal conditions.
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| through study completion, an average of 1 year |
| length of stay in ICU | through study completion, an average of 1 year |