An observational study in Mechanical Ventilation Complication, Surgery and Pulmonary Complication, sponsored by Instituto de Investigacion Sanitaria La Fe. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Observational
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.
1,269 studies on the registry are indexed under Postoperative Complications; 299 are open to participants now.
This study's enrollment of 3,836 is above the median of 251 across 531 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 59 studies on the registry; 15 are open to participants now.
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Adult patients undergoing mechanical ventilation for general anesthesia for surgery.
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Exclusion Criteria:
Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol
Other: High PEEP + Recruitment maneuvers
Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers
Other: Standard PEEP. Low positive end-expriatory pressure
The use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury
Mechanical ventilation is managed with a low standard PEEP without recruitment manneuvers
Incidence of postoperative pulmonary complications
Time frame: Until day seven or hospital discharge, whichever comes first ]
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Instituto de Investigacion Sanitaria La Fe