Pneumothorax Respiratory Pneumothorax
Conditions
Interventions
1. Ambulatory Device, Rocket Pleural vent insertion
2. Standard Treatment, Aspiration +/- chest drain
Sponsors
CTRG (University of Oxford)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presenting with primary spontaneous pneumothorax as confirmed by a chest radiograph or a CT scan 2. Age >= 16 years old and <= 55 years old 3. Ability to consent to participation
Exclusion criteria
Exclusion criteria: 1. Known or suspected underlying lung disease (including >20 pack year smoking history) 2. Evidence of tension pneumothorax (these patients should be treated immediately as medical emergencies). 3. Females who are pregnant or lactating 4. Inability to consent or comply with the trial requirements 5. Contraindication to thoracic procedure. (Only applies to patients being enrolled into Intervention or Control arms – i.e. not observational cohort) 6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether use of an ambulatory device (Rocket Pleural Vent) and treatment strategy reduces hospital stay.Total length of stay in hospital up to 30 days post randomisation.Up to 30 days post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine whether digitally measured air leak and its evolution over treatment, can predict short term clinical trajectory in patients with pneumothorax, including requirement for prolonged drainage and need for thoracic surgical intervention 1.1. Digitally measured air leak (using Thopaz device), from day 0 (immediately post intervention) to day 4 (or until the chest drain/device removal) 1.2. Rate of surgical referral/failure of medical therapy, on day 4 1.3. Number of pleural procedures required during primary admission, from primary admission until completion of treatment 1.4. Rate of lung re-expansion by comparing the percentage of the hemithorax occupied by the pneumothorax using a CXR scoring system, daily until completion of treatment 2. Establish whether radiological evidence (on CT scanning) of emphysema-like changes (ELC) and inflammation, and serum markers of inflammation can predict long term outcome. Measured at 1 week post completion of treatment and 1, 6 and 12 months post enrolment assessed at follow-up clinic. 2.1.CT evidence of ELC and inflammation: number and size of bullae at apices, and bronchial wall thickness in lung apices (surrogate for inflammation), measured at 1 week post completion of treatment and 1, 6 and 12 months post enrolment assessed at follow-up clinic. 2.2. Correlation with recurrence rate (and time to recurrence) assessed at follow-up clinic 2.3. Serum highly sensitive C-reactive protein (CRP) level on blood test. Measured at baseline. 3. Assess whether ambulatory care and early discharge is safe and cost-effective in the treatment of PSP. 3.1. Rate of complications: intervention site bleeding or infection, blockage of device and need for additional procedure. Measured from initial admission until 1 week post completion of treatment. 3.2. NHS-relate | — |
Countries
England, United Kingdom
Outcome results
None listed