An interventional study of Esophageal pressure measurement guided ventilation in Surgery, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
Esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation.
Decades of research and clinical observation in mechanical ventilation have demonstrated unequivocally that tidal volume (VT), plateau pressure (PPLAT) and PEEP (positive end-expiratory pressure) influence ventilator induced lung injury. Clinicians, however, have struggled in the attempt to find a single indicator of safety and risk. Recent analyses of the large multi-center randomized trials database suggest that Airway Driving Pressure (ADP) and Trans pulmonary Driving Pressure (DTP) are the variables of greatest importance and therefore the best single parameters on which to focus. In attempting to define their optimal values and their correlation between each other in the setting of intra-abdominal hypertension, we would like to compare standard of care mechanical ventilation (control) with mechanical ventilation guided by DTP and ADP (intervention) in patients undergoing abdominal laparoscopic surgery.
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Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion criteria:
Patient with contraindication for nasogastric tube placement:
Anesthesia and surgical procedures will be performed following standard of care for mechanical ventilation during surgery.
Same treatment as the control group with the addition of esophageal pressure measurements used to guide mechanical ventilation during surgery.
Other: Esophageal pressure measurement guided ventilation
Use of esophageal pressure measurements to guide mechanical ventilation
Airway driving pressure guided mechanical ventilation determined by esophageal balloon catheter measurements.
Optimizing the relationship between intra-abdominal pressure and both airway driving pressure and trans pulmonary driving pressure utilizing esophageal balloon measurements to guide mechanical ventilation.
Time frame: Through study completion, an average of one year
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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