PleuraFlow Active Clearance Technology (ACT; ClearFlow) is a chest drain that incorporates a tube clearance system.
It comprises a silicone chest tube and the PleuraFlow clearance apparatus. The PleuraFlow clearance apparatus is a PVC guide tube that is used to channel drained blood, fluid and air to the drainage catheter. Inside the guide tube is the clearance guidewire and loop, which moves back and forth inside the chest tube, driven by 2 sets of magnets housed in a shuttle on the outside of the tube. When the shuttle is released and slid along the tube (actuated), the magnets move the guidewire and loop. This pulls blood, clots and any debris toward the drainage canister, which helps to prevent and break up blockages.
The device's instructions for use specify that the PleuraFlow clearance apparatus should be actuated manually inside the chest tube every 15 minutes during the first 8 hours after surgery (when bleeding is more common), then every 30 minutes for the next 16 hours and every hour thereafter. Each actuation takes approximately 10 seconds. The PleuraFlow clearance apparatus should be removed within 5 days (or once bleeding and clotting has stopped, whichever is sooner). The chest tube can then remain in place for up to 2 weeks after being inserted.
The PleuraFlow chest tube is inserted through the chest wall into the pleural or mediastinal space according to local protocols. It is recommended that at least 1 PleuraFlow system is used in the anterior mediastinum, where postoperative bleeding is most common.
PleuraFlow ACT is available in 4 different chest tube sizes: 20, 24, 28 and 32 French. It cannot be used in people who are intolerant to implantable silicone materials.
PleuraFlow ACT differs from standard chest drains in that it incorporates an active tube clearance system. The clearance mechanism is contained within the tube but actuated externally, so the tube remains sterile.
Chest drains are used after all types of cardiothoracic surgery to re‑inflate the lung and to assist with draining air and fluid from the pleural cavity. The NICE guideline on major trauma recommends using chest drains when managing chest trauma in pre-hospital and hospital settings, but there is no NICE guidance on managing chest drains specifically.
The British Thoracic Society guidelines on pleural disease include recommendations for inserting and maintaining chest drains. The guidelines state that chest drains should be connected to a drainage system that contains a valve mechanism to prevent fluid or air from entering the pleural cavity.
PleuraFlow ACT would be used instead of standard chest drains currently used in the NHS. Most NHS trusts have varied local guidelines and protocols for chest drain management, but general principles include regular monitoring of the drain and noting changes that may indicate that the chest tube is kinked or blocked. Stripping and milking of the tubing using roller clamps to remove blockages is no longer recommended.
PleuraFlow ACT is intended for use in adults and children aged over 6 months who need a chest drain after cardiothoracic surgery or trauma. It would be used by healthcare professionals working in secondary or tertiary care who are trained in cardiothoracic surgery. A cardiothoracic surgeon would insert the chest tube in an operating theatre, where it would be connected to the clearance apparatus and a standard drainage system. The patient would then be transferred to an intensive care unit or recovery ward, where nurses would use PleuraFlow ACT to maintain patency of the chest tube until it is removed.
Competency training and education is included in the device cost and provided by the company.
PleuraFlow ACT costs £295 per device (excluding VAT), which includes 1 chest tube and 1 PleuraFlow clearance system.
Standard chest drains without active clearance mechanisms cost approximately £6 each (NHS Supply Chain).
PleuraFlow ACT costs much more than standard chest drains, but this could be offset if its use reduced complications caused by chest tube blockages.
PleuraFlow ACT may also need more staff time than standard chest drains: the recommended actuation schedule equates to 11 minutes of using the device in the first 24 hours after surgery. However, staff time could be reduced if tubes do not need to be manually unblocked or changed.
No changes in facilities and infrastructure would be needed to adopt PleuraFlow ACT, because it can attach to any standard drainage canister.
According to the company, 3 NHS centres are currently using PleuraFlow ACT.