Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Procedure: Recruitment manoeuvers
* Procedure: incremental PEEP


Participation Criteria
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Eligibility Criteria
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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),

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP group<br>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) | Procedure: incremental PEEP<br>* 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<br>|
| Experimental: RM+PEEP group<br>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). | Procedure: Recruitment manoeuvers<br>* Recruitment manoeuvers will be performed as follow Recruitment manoeuvers 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary shunt, expressed as percentage, measured by ALPE system |  | 20 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative driving pressure, measured as plateau pressure - PEEP |  | 20 minutes after intervention |