Schedule of enrolment, interventions and assessments
Both groups | Usual care group | IPC group | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Study procedures | Consent/baseline | Postrandomisation | Days 2–5 | Day 7 | Day 14 | Day 30, 60, 90 | Postrandomisation | Day 4 | Day 7 | Day 14 | Day 30, 60, 90 | Ongoing (between follow-up) |
Sign consent | X | |||||||||||
Demographics/medical history/blood pressure | X | |||||||||||
Randomisation | X | |||||||||||
Local anaesthesia | X | X | ||||||||||
Ultrasound-guided IPC or chest drain insertion | X | X | ||||||||||
Pleural manometry | X | X | ||||||||||
Daily observations (HR, respiratory rate, oxygen requirement, BP, chest drain assessment) drain in situ | X | |||||||||||
Inpatient drainage | X | |||||||||||
Community drainages | X | |||||||||||
Drainage booklet | X | X | ||||||||||
Pleurodesis | X | X | ||||||||||
Drain removal | X | X | ||||||||||
AE data collection | X | X | X | X | X | X | X | X | X | X | X | |
Chest X-ray | X | X | X | X | X | X | X | X* | X | X | X | X |
Thoracic ultrasound | X | X | X | X | X | X | X | X | ||||
VAS assessment (pain and breathlessness) | X | X | X | X | X | X | X | |||||
EORTC QLQ -C30 | X | X | X | X | X | X | X | |||||
MRC Dyspnoea Score | X | X | X | X | X | X | X | |||||
WHO performance status | X |
*Optional CXR based on USS appearances.
AE, adverse events; CXR, chest X-ray; IPC, indwelling pleural catheter; MRC, Medical Research Council; USS, ultrasound scan.