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

NCT03635281 | Completed

• 1 other identifier: OLVRM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• pulmonary shunt, expressed as percentage, measured by ALPE system

  20 minutes after intervention

Secondary Outcomes (1)

• intraoperative driving pressure, measured as plateau pressure - PEEP

  20 minutes after intervention

Other Outcomes (1)

• intraoperative oxygenation, measured as PaO2/FIO2 ratio

  20 minutes after intervention

Study Arms (2)

PEEP group

EXPERIMENTAL

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

RM+PEEP group

EXPERIMENTAL

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).

Procedure: Recruitment manoeuvers

Interventions

Recruitment manoeuvers PROCEDURE

Recruitment manoeuvers will be performed as follow Recruitment manoeuvers 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).

RM+PEEP group

incremental PEEP PROCEDURE

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

PEEP group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing VATS with OLV ≥2 hours

You may not qualify if:

• 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),

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Università di Ferrara

Ferrara, 44121, Italy

Location

Related Publications (2)

• 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.

  PMID: 29215365 RESULT

• 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.

  PMID: 32816177 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: August 17, 2018
• Study Start: August 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: October 30, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

IT (1)