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

U

Università degli Studi di Ferrara

Status

Completed

Conditions

Mechanical Ventilation Complication

Treatments

Procedure: incremental PEEP
Procedure: Recruitment manoeuvers

Study type

Interventional

Funder types

Other

Identifiers

NCT03635281
OLVRM

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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),

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

PEEP group
Experimental group
Description:
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)
Treatment:
Procedure: incremental PEEP
RM+PEEP group
Experimental group
Description:
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).
Treatment:
Procedure: Recruitment manoeuvers

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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