PROTHOR

  • Research type

    Research Study

  • Full title

    PROtective ventilation with high versus low PEEP during one-lung ventilation for THORacic surgery – PROTHOR: A randomized controlled trial

  • IRAS ID

    230191

  • Contact name

    Gary Mills

  • Contact email

    g.h.mills@sheffield.ac.uk

  • Sponsor organisation

    University Hospital Dresden

  • Clinicaltrials.gov Identifier

    NCT02963025

  • Clinicaltrials.gov Identifier

    EK 392092016,

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Major elective surgery has an average mortality of 4%. Breathing problems are the commonest complications. During major surgery most patients require mechanical ventilation to allow adequate transfer of oxygen from the lungs to the blood stream and removal of CO2. Unfortunately, although vital for surgery and life-saving in the critically ill, mechanical ventilation does have disadvantages. It works by blowing air into the lung under positive pressure, rather than drawing it in, as is the case with natural breathing. This means air is distributed to the upper parts of the lung, often causing over stretching of the tissues. Far less air goes to the dependent parts of the lungs, because the air passages here are compressed by the weight of tissues above them, causing air passages to collapse.
    In One-lung ventilation (OLV), the situation is even more complicated, because 1 lung is supporting all the body's needs. OLV is required to allow surgery on the other lung and is part of normal practice. Unfortunately, postoperative lung complications (PPCs) after thoracic surgery employing OLV are common. How to best reduce the incidence of PPCs in terms of ventilation technique isn’t known.
    The aim of this study is to determine what level of pressure should be maintained in the ventilating lung at the end of each breath to prevent the lung collapsing, without causing problems with impeding blood flow through the lung and at the same time reducing postoperative complications. This pressure is called positive end expiratory pressure PEEP. The study compares 2 levels of PEEP, to determine which best reduces lung complications after surgery. As a secondary aim, complications in other body systems, unexpected intensive care admission, number of hospital–free days at day 28, survival rate at day 90, oxygen/CO2 levels will be recorded. In a few centres additional samples will be taken.

  • REC name

    Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

  • REC reference

    18/YH/0236

  • Date of REC Opinion

    20 Aug 2018

  • REC opinion

    Further Information Favourable Opinion