Pneumothorax Respiratory Pneumothorax
Conditions
Interventions
Patients are randomised to treatment with either a seldinger chest drain or to treatment with a Rocket Pleural Vent in a 1:1 ratio through a randomisation server in random permuted blocks.
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. New diagnosis of a secondary spontaneous pneumothorax as confirmed by a chest radiograph or CT scan 2. Secondary spontaneous pneumothorax defined by known underlying lung disease or a patient > 50 years old with a significant smoking history (>20 pack years) 3. Chest drain insertion indicated for treatment of pneumothorax according to current BTS guidelines 4. Chest drain insertion possible at both 2nd intercostal space
Exclusion criteria
Exclusion criteria: 1. Current iatrogenic or traumatic pneumothorax 2. Drain already in place for pneumothorax 3. Previous history of tension pneumothorax 4. Features of tension pneumothorax associated with current presentation 5. Evidence of hydropneumothorax or haemopneumothorax 6. Age <18 years 7. Patients bed-bound prior to pneumothorax 8. Contraindication to either chest drain insertion or rocket pleural vent insertion 9. Females who are pregnant or lactating 10. Patients with no access to a telephone 11. Inability to comply with trial requirements or provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of hospital admission is measured in days by medical record review at the 4 and 12 week visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Breathlessness is assessed using a visual analogue scale (VAS) daily over the first 28 days after randomisation 2. Chest pain is assessed using a visual analogue scale (VAS) daily over the first 28 days after randomisation 3. Quality of life measured using the EQ-5D-5L questionnaire daily over first 14 days after randomisation 4. Number of procedures required for management (including pleural aspirations, chest drain insertion, pleurodesis attempts, thoracic surgical intervention) are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits. 5. Time to drain removal is measured in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits 6. Time to further intervention is measured by in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits. 7. Surgical intervention for pneumothorax is measured in days from randomisation are measured by medical record review at time of patient discharge and medical record review with patient interview at the 4 and 12 visits and 26 weeks phone call. 8. Adverse event rate is measured by patient interview and medical record review at the 4 and 12 visits and 26 weeks phone call. 9. Recurrent pneumothorax is assessed by recording the occurrence of ipsilateral recurrent pneumothorax at end of 26 weeks follow up by patient interview and medical record review | — |
Countries
United Kingdom
Outcome results
None listed