Secondary spontaneous pneumothorax Respiratory
Conditions
Interventions
Study design:
- Randomised controlled trial to see if the intervention (needle aspiration, NA) is non-inferior to standard care (intercostal chest drain, ICD) in patients with secondary spontaneous pn
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (>=18 years of age) with symptomatic SSP will be potentially eligible if: 1. The pneumothorax is of sufficient size and symptoms for the treating physician to consider intervention with ICD, AND 2. The patient has an SSP, defined as a pneumothorax occurring in a patient: 2.1. With known underlying lung disease OR 2.2. >=50 years of age with significant smoking history OR 2.3. With suspected underlying lung disease with radiology confirming structural lung disease
Exclusion criteria
Exclusion criteria: Patients will be excluded if there is: 1. Bilateral pneumothorax 2. Traumatic or iatrogenic pneumothorax 3. Clinical concerns of tension pneumothorax 4. Age <18 years of age 5. Known pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of initial hospital stay (LOHS) from randomisation measured using patient medical notes at Day 30 post-randomisation. Calculated to the nearest hour. Every attempt will be made to collect the date of discharge to calculate LOHS, even if past Day 30, for supporting analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using a numerical rating scale (NRS) daily for the first 5 days post-randomisation and day 30 post-randomisation 2. Breathlessness measured using the MRC dyspnoea scale daily for the first 5 days post-randomisation and Day 30 post-randomisation 3. Patient-reported health status measured using the EQ-5D-5L and SF-36 questionnaire on Day 5 post-randomisation, and Day 30 post-randomisation 4. Total number of days in hospital including readmissions measured using patient medical notes at Day 30 post-randomisation. Calculated to the nearest hour. Every attempt will be made to collect these dates of discharge to calculate LOHS, even if past Day 30, for supporting analyses 5. Immediate treatment success: 5.1. For NA, success is defined by persistent adequate responses following the aspirations. 5.2. For ICD, success is defined by an adequate response with the removal of a drain within 72 hours of drain insertion 6. Hospital readmission measured using patient medical notes on Day 30 post-randomisation 7. Fitness and frailty measured using the Clinical frailty score Post-intervention and Day 5 post-randomisation 8. Pneumothorax resolution on X-ray measured using patient medical notes on Day 30 post-randomisation 9. Total number of subsequent pleural procedures measured using patient medical notes within first 24 hours and up to 30 days post-randomisation 10. Mortality measured using patient medical notes Day 30 post-randomisation 11. Hospital resource use up to 30 days, including emergency, admitted, critical and outpatient care measured using patient medical notes on Day 30 post-randomisation 12. Cost effective and utility measured using a health economics resource use questionnaire on Day 30 post-randomisation | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactStudy Team
Outcome results
None listed