Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT02671721
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.
Time frame: During abdominal surgery
We will assess intraoperative driving pressure to evaluate respiratory mechanics during surgery.
Time frame: During abdominal surgery
We will assess intraoperative transpulmonary pressure to evaluate respiratory mechanics during surgery.
Time frame: During abdominal surgery
We will assess intraoperative respiratory system compliance to evaluate respiratory mechanics during surgery.
Time frame: During abdominal surgery
We will assess intraoperative PEEP values and their variability between patients and during surgery.
Time frame: During abdominal surgery
We will assess intraoperative oxygenation and carbon dioxide elimination.
Time frame: During abdominal surgery
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).
Time frame: Within the first 7 postoperative days.
We will assess the incidence and absolute number of postoperative pulmonary complications within the first 7 postoperative days.
Massachusetts General Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03726086
Complication of Ventilation Therapy, Critical Illness
Baltimore, Maryland, United States
View Trial DetailsNCT02740075
Complication of Ventilation Therapy
La Jolla, California, United States
View Trial DetailsNCT03420937
Complication of Ventilation Therapy, Observation of Neuromuscular Block
Olomouc, Czechia
View Trial DetailsNCT02318810
Complication of Ventilation Therapy, Muscle Hypotonia
Rostock, Mecklenburg-Vorpommern, Germany
View Trial Details