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

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

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 Overview

• Status: Completed
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: incremental PEEP; Procedure: Recruitment manoeuvers

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Università di Ferrara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Procedure: 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
EXPERIMENTAL: 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).	Procedure: Recruitment manoeuvers; 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
intraoperative oxygenation, measured as PaO2/FIO2 ratio	20 minutes after intervention

Collaborators and Investigators

• Sponsor: Università degli Studi di Ferrara

Publications and helpful links

General Publications

• Spadaro S, Grasso S, Karbing DS, Fogagnolo A, Contoli M, Bollini G, Ragazzi R, Cinnella G, Verri M, Cavallesco NG, Rees SE, Volta CA. Physiologic Evaluation of Ventilation Perfusion Mismatch and Respiratory Mechanics at Different Positive End-expiratory Pressure in Patients Undergoing Protective One-lung Ventilation. Anesthesiology. 2018 Mar;128(3):531-538. doi: 10.1097/ALN.0000000000002011.
• Spadaro S, Grasso S, Karbing DS, Santoro G, Cavallesco G, Maniscalco P, Murgolo F, Di Mussi R, Ragazzi R, Rees SE, Volta CA, Fogagnolo A. Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation. J Clin Monit Comput. 2021 Oct;35(5):1149-1157. doi: 10.1007/s10877-020-00582-z. Epub 2020 Aug 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): September 30, 2018
• Study Completion (ACTUAL): October 30, 2018

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (ACTUAL): August 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: OLVRM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No