Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Lung Diseases
  • Obesity
  • One Lung Ventilation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Mechanical ventilation with individualized PEEP will be compared to mechanical ventilating with low PEEP during lung isolation in each subject. Each subject will receive one PEEP level then will receive the second PEEP level. The order in which each subject receives the PEEP level will be randomized.Masking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

During surgery on the lung, ventilation of one lung at a time is often necessary. During thoracic surgery requiring one-lung ventilation (OLV), hypoxemia (reduced oxygen tension in blood) can present a clinical challenge. Due to multiple factors, the likelihood of hypoxemia during OLV in obese patie...

During surgery on the lung, ventilation of one lung at a time is often necessary. During thoracic surgery requiring one-lung ventilation (OLV), hypoxemia (reduced oxygen tension in blood) can present a clinical challenge. Due to multiple factors, the likelihood of hypoxemia during OLV in obese patients is increased. Atelectasis (collapse of the lung airspaces) contributes to hypoxemia and can be mitigated by application of recruitment maneuvers and positive end-expiratory pressure (PEEP). A recruitment maneuver is a breath given in a mechanically ventilated patient that helps to open up collapsed air spaces, and PEEP is application of a continuous amount of positive pressure that helps keep the air spaces open at the end of an exhaled breath. Adjusting the level of PEEP to each individual patient's optimal lung compliance (individualized PEEP) improves blood oxygen levels compared to application of standard low PEEP (5 cmH2O); however, higher levels of PEEP required to achieve optimal lung compliance could increase intrathoracic pressures to a level that impedes normal circulation. This could negatively affect blood flow (cardiac output) and delivery of oxgyen to vital organs. Evidence addressing OLV in obese patients is lacking. The purpose of this study is to compare brain oxygen levels (cerebral oxygen saturation) and measures of blood flow and gas exchange during OLV with individualized PEEP vs low standard PEEP in obese patients undergoing thoracic surgery. To our knowledge, there is no previous study that compares oxygen delivery to vital organs (such as the brain) during OLV using individualized PEEP versus standard low PEEP, in an obese patient population. In this study, subjects undergoing OLV during surgery to remove a portion of the lung (lobectomy) will undergo a process to determine their individualized PEEP and then two 20-minute experimental periods-- one period with OLV with low PEEP and one period with OLV with individualized PEEP. Measurements of cerebral oxygen saturation, blood oxygen levels, cardiac output, and blood pressure medication dose will be measuring before and after these experimental periods during surgery.

Tracking Information

NCT #
NCT03569774
Collaborators
Not Provided
Investigators
Principal Investigator: Dionne Peacher, MD University of Iowa