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Clinical Trials/NCT02963025
NCT02963025
Completed
Not Applicable

PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR: A Randomized Controlled Trial

Technische Universität Dresden79 sites in 21 countries2,200 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
One-Lung Ventilation
Sponsor
Technische Universität Dresden
Enrollment
2200
Locations
79
Primary Endpoint
The proportion of patients developing one or more postoperative pulmonary complications
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

One-lung ventilation (OLV) with resting of the contralateral lung may be required to allow or facilitate thoracic surgery. However, OLV can result in severe hypoxemia, requiring a mechanical ventilation approach that is able to maintain adequate gas exchange, while protecting the lungs against postoperative pulmonary complications (PPCs). During OLV, the use of lower tidal volumes is helpful to avoid over-distension, but can result in increased atelectasis and repetitive collapse-and-reopening of lung units, particularly at low levels of positive end-expiratory pressure (PEEP).

Anesthesiologists inconsistently use PEEP and recruitment maneuvers (RM) in the hope that this may improve oxygenation and protect against PPC. Up to now, it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV.

Hypothesis: An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
August 1, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
  • BMI \< 35 kg/m2
  • age ≥ 18 years
  • expected duration of surgery \> 60 min
  • planned lung separation with double lumen tube (DLT, not for study purpose only)
  • most of ventilation time during surgery expected to be in OLV

Exclusion Criteria

  • COPD GOLD grades III and IV, lung fibrosis, documented bullae, severe emphysema, pneumothorax
  • uncontrolled asthma
  • Heart failure NYHA Grade 3 and 4, Coronary Heart Disease CCS Grade 3 and 4
  • previous lung surgery
  • documented pulmonary arterial hypertension \>25mmHg MPAP at rest or \> 40 mmHg syst. (estimated by ultrasound)
  • documented or suspected neuromuscular disease (thymoma, myasthenia, myopathies, muscular dystrophies, others)
  • planned mechanical ventilation after surgery
  • bilateral procedures
  • lung separation with other method than DLT (e.g. difficult airway, tracheostomy)
  • surgery in prone position

Outcomes

Primary Outcomes

The proportion of patients developing one or more postoperative pulmonary complications

Time Frame: 90 days

Study Sites (79)

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