Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone on Ventilation Perfusion Mismatch and Respiratory Mechanics in One Lung Ventilation. A Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- pulmonary shunt, expressed as percentage, measured by ALPE system
Study Overview
Brief Summary
The intraoperative driving pressure (∆P) has been recently identified as the greater independent predictor of postoperative pulmonary complications after one lung ventilation (OLV). The application of a positive end-expiratory pressure (PEEP) level of 5 or 10 cmH2O has been shown to reduce the ∆P and the V/Q mismatch (Spadaro 2017); however, the "optimal" PEEP level able to minimize the ∆P may change significantly across patients. The aim of this study is to describe the optimal PEEP levels in patients undergoing thoracic surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing VATS with OLV ≥2 hours
Exclusion Criteria
- •ASA (American Society of Anesthesiologists Physical Status Classification) score ≥ 4
- •severe chronic respiratory failure (chronic obstructive pulmonary disease patients with GOLD stage 3 or 4
- •preoperative hemoglobin less than 10 g ml-1
- •hemodynamic instability (defined as a decrease in systolic arterial pressure of more than 20% from baseline),
Arms & Interventions
PEEP group
In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached)
Intervention: incremental PEEP (Procedure)
RM+PEEP group
Recruitment maneuvers will be performed as follow Recruitment maneuvers
- set FIO2 at 1.0
- Ppeak limit at 45 cmH2O
- Respiratory rate set at 6
- I:E set at 1:1
- Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
- If the maximum VT is set without rasing the Pplat, raise PEEP
- Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
- End of RM
The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached).
Intervention: Recruitment manoeuvers (Procedure)
Outcomes
Primary Outcomes
pulmonary shunt, expressed as percentage, measured by ALPE system
Time Frame: 20 minutes after intervention
Secondary Outcomes
- intraoperative driving pressure, measured as plateau pressure - PEEP(20 minutes after intervention)
Investigators
Savino Spadaro
Professor, PhD
Università degli Studi di Ferrara