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Completed

NCT Number: NCT03635281

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

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

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università di Ferrara

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

Recruitment manoeuvers

Procedure

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).

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

Primary outcomes

  1. pulmonary shunt, expressed as percentage, measured by ALPE system

    Time frame: 20 minutes after intervention

Secondary outcomes

  1. intraoperative driving pressure, measured as plateau pressure - PEEP

    Time frame: 20 minutes after intervention

Other outcomes

  1. intraoperative oxygenation, measured as PaO2/FIO2 ratio

    Time frame: 20 minutes after intervention

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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