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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care mechanical ventilation | No Intervention | Anesthesia and surgical procedures will be performed following standard of care for mechanical ventilation during surgery. | |
| Transpulmonary pressure guided mechanical ventilation | Active Comparator | Same treatment as the control group with the addition of esophageal pressure measurements used to guide mechanical ventilation during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal pressure measurement guided ventilation | Other | Use of esophageal pressure measurements to guide mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of one year |
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Inclusion Criteria:
Exclusion criteria:
Patients with open abdomen prior to surgical procedures.
Females of childbearing age (18-50) with the potential to become pregnant and no clinically documented negative pregnancy test.
Patients with clinically evident spontaneous breathing efforts (ventilator wave forms) during surgical procedure.
Patients with clinical suspicion of elevated intra-cranial pressure (requiring head elevation).
Contraindication to body position change, as dictated by surgery-specific protocol.
Unstable cardio-respiratory insufficiency.
Age less than 18 years.
Cuff leak in endotracheal / tracheostomy tube.
Patient/responsible family member unable to understand the informed consent in English.
Patient with contraindication for nasogastric tube placement:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Oeckler, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Randomization to two different groups.
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This is a prospective, open label, randomized study
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