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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication
• Interventions: Procedure: Recruitment manoeuvers; Procedure: incremental PEEP

• Registration Number: NCT03635281
• Lead Sponsor: Università degli Studi di Ferrara

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-17
• Primary Completion: 2018-09-30
• Study Completion: 2018-10-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RM+PEEP group	Recruitment manoeuvers	Recruitment maneuvers will be performed as follow Recruitment maneuvers 1. set FIO2 at 1.0 2. Ppeak limit at 45 cmH2O 3. Respiratory rate set at 6 4. I:E set at 1:1 5. Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O 6. If the maximum VT is set without rasing the Pplat, raise PEEP 7. Allow three respiratory cycles with Pplat between 30 and 40 cmH2O 8. 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).
PEEP group	incremental PEEP	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)

Primary Outcome Measures

Name	Time	Method
pulmonary shunt, expressed as percentage, measured by ALPE system	20 minutes after intervention

Secondary Outcome Measures

Name	Time	Method
intraoperative driving pressure, measured as plateau pressure - PEEP	20 minutes after intervention

Trial Locations

Locations (1)

Università di Ferrara; 🇮🇹 Ferrara, Italy