Conservative versus Interventional Treatment for Spontaneous Pneumothorax

Abstract

BACKGROUND Whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large primary spontaneous pneumothorax is unknown. METHODS In this open-label, multicenter, noninferiority trial, we recruited patients 14 to 50 years of age with a first-known, unilateral, moderate-to-large primary spontaneous pneumothorax. Patients were randomly assigned to immediate interventional management of the pneumothorax (intervention group) or a conservative observational approach (conservative-management group) and were followed for 12 months. The primary outcome was lung reexpansion within 8 weeks. RESULTS A total of 316 patients underwent randomization (154 patients to the intervention group and 162 to the conservative-management group). In the conservativemanagement group, 25 patients (15.4%) underwent interventions to manage the pneumothorax, for reasons prespecified in the protocol, and 137 (84.6%) did not undergo interventions. In a complete-case analysis in which data were not available for 23 patients in the intervention group and 37 in the conservative-management group, reexpansion within 8 weeks occurred in 129 of 131 patients (98.5%) with interventional management and in 118 of 125 (94.4%) with conservative management (risk difference, −4.1 percentage points; 95% confidence interval [CI], −8.6 to 0.5; P = 0.02 for noninferiority); the lower boundary of the 95% confidence interval was within the prespecified noninferiority margin of −9 percentage points. In a sensitivity analysis in which all missing data after 56 days were imputed as treatment failure (with reexpansion in 129 of 138 patients [93.5%] in the intervention group and in 118 of 143 [82.5%] in the conservative-management group), the risk difference of −11.0 percentage points (95% CI, −18.4 to −3.5) was outside the prespecified noninferiority margin. Conservative management resulted in a lower risk of serious adverse events or pneumothorax recurrence than interventional management. CONCLUSIONS Although the primary outcome was not statistically robust to conservative assumptions about missing data, the trial provides modest evidence that conservative management of primary spontaneous pneumothorax was noninferior to interventional management, with a lower risk of serious adverse events.

Research capacity of Australian and New Zealand emergency medicine departments

“…Ninety-six EDs contributed to multicentre research during the last 5 years. Fifty-two EDs contributed to ACEM CTN projects, mainly collecting data for the ARISE sepsis fluids observational study (n = 52) and the spontaneous pneumothorax study (n = 19) [11,16].…”

“…As we evaluate treatment options, particularly for critically ill patients, we discover many current established therapies have limited efficacy [4,5]. Multicentre randomised studies have recently been published on core topics such as fluids in sepsis, bronchiolitis management, latrodectism and pneumothorax recommending fundamental changes to patient management [6][7][8][9][10][11].…”

Conservative versus interventional treatment for spontaneous pneumothorax

“…Before the current trial, there were a few observational studies suggesting that moderate to large sized PSPs can potentially be successfully managed without intervention but evidence from randomised trials was lacking [2]. The PSP trial aimed to determine whether conservative management is an acceptable alternative to interventional management for uncomplicated, moderate-to-large PSP [3].…”

Research capacity of Australian and New Zealand emergency medicine departments, 2019 survey

“…Ninety-six EDs contributed to multicentre research during the last 5 years. Fifty-two EDs contributed to ACEM CTN projects, mainly collecting data for the ARISE sepsis fluids observational study (n=52)(16) and the spontaneous pneumothorax study (n=19) (11).…”

“…As we evaluate treatment options, particularly for critically ill patients, we discover many current established therapies have limited efficacy (4,5). Multicentre randomised studies have recently been published on core topics such as fluids in sepsis (6,7), bronchiolitis management (8,9), latrodectism (10) and pneumothorax (11)recommending fundamental changes to patient management.…”