None listed
Conditions
Brief summary
Primary spontaneous pneumothorax occurs when a lung collapses due to air escaping from a small hole in the surface lining. It occurs predominantly in young people who have no other lung disease. The symptoms are variable but may include chest pain and breathlessness. Currently the treatment recommended by international guidelines is to try to remove the air from the chest and re-expand the lung by inserting a plastic tube through the chest wall. This is done using local anaesthetic but can be uncomfortable and may be associated with complications. It may take up to a week for the lung to re-inflate, during which time the patient must remain in hospital. In some cases air continues to leak out of the lung and surgery is required. However, there are historical reports suggesting that simply observing a pneumothorax and allowing it to re-expand slowly may be as effective as inserting a tube in hospital, although it may take 4-6 weeks to fully resolve. This study will compare the current standard treatment using a tube, to simple observation, in a group of 342 patients with pneumothorax. The proportion in each group who have resolved on an X-ray at 8 weeks will be compared.
Interventions
Conservative management of primary spontaneous pneumothorax. Subjects will be observed for 4 hours in the emergency department and a repeat x-ray taken. If they are clinically stable and able to mobilise comfortably they will be discharged home and followed as an outpatient with a review at 24-72 hours, and at 2, 4 and 8 weeks.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
14 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Primary spontaneous pneumothorax that is 32% or larger (using method of Collins et al Am J Roentgenol. 1995; 165: 1127-30)
Exclusion criteria
Secondary pneumothorax, defined as pneumothorax occurring in the setting of acute trauma (including iatrogenic) or underlying lung disease including but not limited to COPD, pulmonary fibrosis, TB, cystic fibrosis, lung cancer and asthma that requires regular preventative medication or has been symptomatic within the last two years 2. Previous spontaneous pneumothorax on the same side 3. Coexistent haemothorax (i.e. spontaneous haemopneumothorax) 4. Bilateral pneumothorax 5. Clinical instability suggesting tension pneumothorax; respiratory distress persisting despite oxygen and parenteral narcotic analgesia (RR >30/min or SpO2 <90%), SBP <90 mmHg, HR greater than or equal to SBP. 6. Pregnancy at time of enrolment 7. Social circumstances whereby the patient either does not have adequate support after discharge to re-attend hospital if required, or is unlikely to present for study follow up. 8. Air travel within the next 12 weeks if this cannot be deferred should the pneumothorax be slow to resolve"
Outcome results
None listed