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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Hospital Israelita Albert Einstein | OTHER |
| University Hospital Carl Gustav Carus | OTHER |
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The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers.
Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High PEEP + Recruitment Maneuvers | Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol |
| |
| Standard PEEP | Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High PEEP + Recruitment maneuvers | Other | The use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative pulmonary complications | Until day seven or hospital discharge, whichever comes first ] |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | SĂŁo Paulo | Brazil | ||||
| IRCCS San Martino Policlinico Hospital |
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| Label | URL |
|---|---|
| Association between ventilation parameter and postoperative complications | View source |
| PROBESE Study | View source |
| iPRVE study |
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| Hospital ClĂnico Universitario de Valencia |
| OTHER |
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| Standard PEEP. Low positive end-expriatory pressure | Other | Mechanical ventilation is managed with a low standard PEEP without recruitment manneuvers |
|
| Genoa |
| Italy |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Amsterdam | Netherlands |
| Hospital Clinic | Barcelona | Spain |
| PROVHILO study | View source |
| The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patients | View source |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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