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RELEASE

RELEASE is part of the CoReCCT Group of Trials

Approximately 130,000 adults are admitted to intensive care units (ICUs) in the UK each year, 40-45% of whom require invasive mechanical ventilation (IMV). Acute hypoxaemic respiratory failure (AHRF) is the most common reason for IMV and is associated with serious morbidity and a mortality which remains high at ~40%. 

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Airway Pressure Release Ventilation (APRV) is an innovative ventilatory strategy available on all ICU ventilators at no additional cost to the National Health Service (NHS). APRV may improve gas exchange and minimise VILI by reducing excessive lung stretch and preventing lung collapse.

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RELEASE aims to investigate, using a multi-centre, parallel group, pragmatic, randomised controlled trial design, the clinical and cost effectiveness of early APRV compared to conventional lung protective invasive mechanical ventilation (IMV) in patients with moderate-severe acute hypoxic respiratory failure (AHRF).

INCLUSION CRITERIA

  1. Age ≥ 18 years

  2. Tracheal intubation and receiving invasive mechanical ventilation

  3. Moderate to severe AHRF (PaO2/FiO2 <20kPa with Positive End Expiratory Pressure (PEEP) ≥5 cmH2O assessed at time of screening (or as documented in the medical record in the preceding 2 hours) for trial inclusion

  4. Expected to require invasive mechanical ventilation for >48 hours

EXCLUSION CRITERIA

  1. Primary reason for invasive mechanical ventilation is one of the following:

    1. Asthma

    2. Severe COPD

    3. Pulmonary embolism (massive or sub-massive) (as cause of hypoxaemia is not primarily due to collapse of lung tissue)

    4. Existing neuromuscular disease such as Motor Neurone Disease, Guillain Barre or Myasthenia Gravis (as the cause of respiratory failure is not primarily lung-related)

  2. Refractory shock (systolic blood pressure < 90 mmHg, despite fluid administration and vasoactive drugs)*

  3. Severe hypercapnic respiratory acidosis (pH <7.20 on the arterial blood gas assessed for trial inclusion)*

  4. Pneumothorax with ongoing air leak*

  5. Traumatic brain injury with uncontrolled intracranial hypertension*

  6. Likely death or treatment withdrawal in next 24 hours

  7. Home ventilation or home oxygen therapy prior to admission

  8. Receiving IMV ≥ 48 hours at time of screening as will be unable to deliver early APRV

  9. Declined consent

Study Information

The RELEASE trial should be generally easy to embed at Kings. The PI is Dr Tasneem Pirani. The Sub-PI is Elton Gelandt.

The API  role is open

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© 2035 by Dr Phil Hopkins

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