Primary spontaneous pneumothorax Respiratory
Conditions
Interventions
This study is an open-label multicentre, parallel two-group, individually randomised controlled trial with an internal pilot phase, parallel cost-effectiveness analysis and active participant follow-u
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 03/07/2025: 1. Symptomatic primary spontaneous pneumothorax of sufficient size to allow intervention 2. Aged between 16 and 50 years old (inclusive) Previous key inclusion criteria: 1. Primary spontaneous pneumothorax of sufficient size and symptoms, where the treating physician is considering an intervention 2. Aged between 16 and 50 years old (inclusive)
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 03/07/2025: 1. Known or suspected underlying lung disease* 2. Evidence of clinical tension pneumothorax 3. SpO2 <92% on air 4. Bilateral pneumothorax 5. Pregnancy 6. Inability to consent or comply with trial requirements * Mild/well-controlled asthma is not considered an exclusion criterion. Patients with a diagnosis of asthma who are well-controlled on standard prescribed inhaler therapy remain eligible for participation in this study. Previous key inclusion criteria: 1. Known or suspected underlying lung disease* 2. Evidence of clinical tension pneumothorax 3. SpO2 <92% on air 4. Bilateral pneumothorax 5. Pregnancy 6. Inability to consent or comply with trial requirements * “Childhood asthma” or well-controlled asthma is not considered an exclusion criterion. Patients with a diagnosis of asthma in childhood/young adulthood who do not require the use of a regular “preventer” inhaler (i.e. inhaler containing a steroid or long-acting beta-agonist), and only occasionally use a “reliever” inhaler (short-acting beta-agonist) and have never been hospitalised due to asthma remain eligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any pleural procedure (intercostal drain insertion, needle aspiration, pleural vent, video-assisted thoracoscopy) measured using patient medical notes at any time after randomisation and completion of initial care up to 30 days after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days in the hospital measured using patient medical notes up to 30 days after randomisation, including initial hospital stay and re-admissions 2. Pain and breathlessness measured using visual analogue scale (VAS) scores collected using an online application at baseline, 48 hours, and 14 and 30 days 3. Health-related quality of life measured using the participant-reported health status questionnaire (EQ-5D-5L) collected using an online application at baseline, 48 hours, and 14 and 30 days 4. Perceived participant acceptability of the intervention or comparator measured using a study-specific online questionnaire at 30 days 5. Radiographic resolution of PSP measured using a study-specific chest x-ray at 30 days 6. Adverse events measured using patient medical notes up to 30 days 7. Total number of subsequent pleural procedures measured using patient medical notes up to 30 days 8. Time to return to work (if employed) measured using a questionnaire at 30 days 9. Hospital resource use, including emergency, admitted, critical and outpatient care measured using routine data sources such as NHS Digital for up to 12 months 10. Time to recurrence of pneumothorax measured using routine data sources such as NHS Digital up to 12 months | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLucy Hamilton
Outcome results
None listed