NCT02671721

Intraoperative Protective Ventilation and Postoperative Pulmonary Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Complication of Ventilation Therapy
• Postoperative Respiratory Complications

Interventions

Type	Name	Description
OTHER	Maximal Compliance	PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
OTHER	Transpulmonary Pressure	We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-03-01
• Completion: 2017-06-01
• First posted: 2016-02-02
• Last updated: 2019-02-08

Locations

1 site across 1 country: United States