Projects

Research subject
PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery PROTHOR: A randomized controlled trial
Institution
Juntendo University Hospital
Principal investigator
Izumi Kawagoe
Contact (email)
ikawago@juntendo.ac.jp
Study outline
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.
  • Area of the study
    Other than cancer
    Development items
    Medical devices
    Regulatory approval
    ---
    Main country where studies are conducted
    Led by a country abroad
    Leading country name:(Germany, Turkey)
    Number of participating countries, Number of participating institutions
    Number of participating countries:17, Number of participating institutions:79
    Participating countries' names
    ---
    Study design
    Interventional study
    Development phase
    Others
    Sample size
    2378以上
  • Website
    Registered(NCT02963025)
    Intellectual property
    Yes
    Preclinical study
    ---
    Sponsoring company
    No
    Planning of licensing-out
    Not planned
    Domestic funding
    No
    Funding abroad
    Yes in some of the countries
    Contract
    ---
    Procurement of investigational product
    Completed in all countries
  • Steering Committee
    Yes
    Development roadmap
    Fixed
    Stage of the study
    In the process of patient registration
    Protocol
    Using a single protocol as a single study
    IRB application
    Completed in all countries
    Data management
    Abroad
    Monitoring
    None
    Consultation with regulatory authorities
    Completed in some of the countries
Current issues & challenges
(request for support, etc.)
---

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