Pneumothorax Collapsed lung
Conditions
Interventions
Patients will be allocated at random (1:1 with random blocks per site) to tube thoracostomy (control group) or non-invasive treatment (intervention group). Both treatments are standard care. Tube thor
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age 16-80 yearsBlunt traumatic pneumothorax, with size 15-50% on X-rayHospital presentation <24h after traumaHemodynamically and respiratory within physiological boundaries spontaneously or after resuscitationProvision of informed consent by patient or proxy
Exclusion criteria
Exclusion criteria: Bilateral pneumothoracesPlanned transfer to other hospital <24 hours after admissionPatient moribundEmergency (Department) Thoraco(s)tomyHemothorax (associated with pneumothorax) requiring tube thoracostomyTension pneumothorax at the time of randomizationExpected problems with follow-up, e.g., patient without fixed addressInsufficient Dutch or English [Ev1] language comprehension (even with support)Surgical intervention that might influence any of the outcome parametersParticipation in another surgical intervention study that might influence any of the outcome parameters
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is pneumothorax resolution within 6 weeks after trauma. | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary outcome measure is pneumothorax resolution within 6 weeks after trauma. Secondary outcome measures are: 1) emergency pleural intervention; 2) Complications; 3) all-cause and pneumothorax or chest trauma-related mortality; 4) pain level at the pneumothorax location during six activities (during maximal inspiration, at rest, at night, and during coughing, daily activities, and self-care) and analgesic drug use; 5) modified Medical Research Council (mMRC) dyspnea scale; 6) hospital length of stay (HLOS) and ICU length of stay (ICU LOS); 7) EQ-5D-5L; 8) (in)direct health care use and work absence including associated costs; 9) incremental cost-utility ratio (ICUR) of non-invasive treatment over tube thoracostomy, expressed as the incremental costs per quality adjusted life years (QALY; based on EQ-5D-5L) gained until 6 months; and 10) incremental cost-effectiveness ratio (ICER) of non-invasive treatment over tube thoracostomy, expressed as the incremental costs per secondary tube placement within 6 weeks. | — |
Countries
Netherlands
Contacts
Public ContactM.M.E. Wijffels
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed