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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of Colorado, Denver | OTHER |
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The purpose of this pilot study is to identify the optimal way to ventilate patients during abdominal surgery in order to reduce the amount of post-operative pulmonary complications in patients at moderate and high-risk for them.
The investigators plan to prospectively compare two methods to individualize Positive End Expiratory Pressure (PEEP) settings in the operating room during abdominal surgery: (1) Maximization of respiratory compliance during a decremental PEEP titration, and (2) Prevention of negative end-expiratory transpulmonary pressures.
The investigators will exploit the usual intraoperative requirement for a naso/orogastric tube to assess transpulmonary pressures,and respiratory mechanics measurements from anesthesia machines to titrate PEEP.
The investigators will measure biomarkers of lung injury and lung function to compare those methods between themselves and to the control group. In the process, the investigators will assess the ease and reliability of anesthesia teams in implementing the methods. These data will allow us to determine the PEEP strategy best suited for the full-scale trial, and to estimate the degree of separation the experimental lung protective approach will have from the protocolized usual care control settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Strategy | No Intervention | Patients will receive usual and prudent PEEP and tidal volume settings. | |
| Maximal Compliance Strategy | Experimental | PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve. |
|
| Transpulmonary Pressure Strategy | Experimental | Personal PEEP titration using transpulmonary pressures obtained from a naso/orogastric tube containing an esophageal balloon port |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maximal Compliance | Other | PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative driving pressure | We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery. | During abdominal surgery |
| Intraoperative transpulmonary pressure | We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery. | During abdominal surgery |
| Intraoperative respiratory system compliance | We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery. | During abdominal surgery |
| Intraoperative positive end-expiratory pressure (PEEP) levels | We will assess intraoperative PEEP values and their variability between patients and during surgery. | During abdominal surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative gas exchange | We will assess intraoperative oxygenation and carbon dioxide elimination. | During abdominal surgery |
| Plasma levels of biomarkers of lung injury | We will assess plasma concentrations of biomarkers of lung injury before and after surgery, including biomarkers of inflammation (interleukin-6, IL-6, interleukin-8, IL-8), epithelial injury (soluble form of the receptor for advanced glycation end-products, sRAGE, Club Cell protein-16, CC16), endothelial injury (angiopoietin-2, Ang-2), and endothelial-derived coagulation activation (plasminogen activator inhibitor-1, PAI-1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32682559 | Derived | Fernandez-Bustamante A, Sprung J, Parker RA, Bartels K, Weingarten TN, Kosour C, Thompson BT, Vidal Melo MF. Individualized PEEP to optimise respiratory mechanics during abdominal surgery: a pilot randomised controlled trial. Br J Anaesth. 2020 Sep;125(3):383-392. doi: 10.1016/j.bja.2020.06.030. Epub 2020 Jul 16. |
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| Transpulmonary Pressure | Other | We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively. |
|
| During abdominal surgery |
| Postoperative Pulmonary Complications | We will assess the incidence and absolute number of postoperative pulmonary complications within the first 7 postoperative days. | Within the first 7 postoperative days. |