Background: Management of primary spontaneous pneumothorax is usually with the insertion of a chest tube and typically requires hospitalization. This procedure can result in pain, organ injury, bleeding, and infection, and, if unresolved, may require surgery, introducing additional risks and complications. Few data exist from randomized trials comparing conservative versus interventional management.
Study design: Open-label, multicenter, prospective, randomized, noninferiority trial.
Setting: A total of 39 metropolitan and rural hospitals in Australia and New Zealand.
Synopsis: Overall, 316 patients with moderate to large primary spontaneous pneumothorax were randomized (154 to the intervention group and 162 in the conservative group). In the conservative group, 25 patients (15.4%) required eventual intervention for prespecified reasons (uncontrolled pain, chest pain or shortness of breath preventing mobilization, clinical instability, enlarging pneumothorax).
In complete-case analysis, 129 out of 131 (98.5%) patients in the intervention group had resolution within 8 weeks, compared with 118 of 125 (94.4%) in the conservative group (risk difference, –4.1 percentage points; 95% confidence interval, –8.6 to 0.5, P = .02 for noninferiority).
In sensitivity analysis, in which missing data after the 8-week period were imputed as treatment failures, re-expansion occurred in 129 out of 138 (93.5%) patients in the intervention group and 118 out of 143 (82.5%) in the conservative group (risk difference, –11.0 percentage points; 95% CI, –18.4 to –3.5), which is outside the noninferiority margin of –9.0.
Overall, 41 patients in the intervention group and 13 in the conservative group had at least one adverse event.
Bottom line: Missing data limit the ability to make strong conclusions, but this trial suggests that conservative management of primary spontaneous pneumothorax was noninferior to interventional management with lower risk of serious adverse events.
Citation: Brown SG et al. Conservative versus interventional treatment for spontaneous pneumothorax..
Dr. Schmit is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.