Heimlich Valves in Secondary Spontaneous Pneumothorax: Enhancing Care
Research type
Research Study
Full title
Heimlich Valves in Secondary Spontaneous Pneumothorax: Enhancing Care (Hi-SPEC)
IRAS ID
187812
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust
ISRCTN Number
ISRCTN79956557
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A pneumothorax is a collection of air around the lung within the chest which can be due to an injury puncturing the lung or due to a leak of air from the lung. A leak of air from the lung can occur spontaneously in patients without lung disease (Primary spontaneous pneumothorax) or in patients with known previous lung disease (Secondary spontaneous pneumothorax). When a pneumothorax occurs, the lung collapses often causing breathlessness and chest pain. The treatment of a pneumothorax frequently involves a tube being inserted into the space around the lung to allow the air to escape and the lung to inflate again.\nThe tube inserted in the space around the lung is usually connected to an ‘underwater seal’ with the tip of the tube in a bottle of sterile water. This allows air to escape from the chest by bubbling through the water. An alternative device is a Heimlich valve, which is an enclosed valve connected to a chest tube.\nStudies have shown that Heimlich valves can be useful for the treatment of pneumothorax and may allow patients to be treated at home. For patients with lung disease and secondary spontaneous pneumothorax there are studies suggesting that these valves are safe and have some advantages, but there are no trials directly comparing them against standard treatment.\nThis study will randomly allocating patients with secondary spontaneous pneumothorax to a Heimlich valve or to an underwater seal, in order to allow a fair comparison. The study will particularly assess how long patients are in hospital for, patients’ quality of life, levels of chest pain and breathlessness, how many other procedures are required for treatment, whether surgery is needed and readmissions to hospital. We will also assess if treatment affects pneumothorax happening again, or any problems related to the procedures.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
16/SW/0023
Date of REC Opinion
14 Mar 2016
REC opinion
Further Information Favourable Opinion