Abstract
BACKGROUND: Primary spontaneous pneumothorax (PSP) is the accumulation of air in the pleural space without underlying lung disease. Standard management often involves chest tube insertion connected to an underwater seal drainage system (bottle), but alternatives like the Heimlich one-way valve exist. This study aimed to compare the clinical outcomes of using a Heimlich valve versus standard chest tube drainage for PSP. METHODS: This was a single-center, open-label, parallel-group randomized controlled trial conducted at Shahid Madani Hospital, Karaj, Iran, from March 2023 to March 2024. Forty patients aged 18-40 years with symptomatic PSP (>15% collapse) were randomized (1:1 ratio) using block randomization. The intervention group received a 28 Fr chest tube connected to a Heimlich valve. The control group received a 28 Fr chest tube attached to an underwater sealed bottle. Primary outcomes included length of hospital stay, time to return to normal activities other outcomes included pain scores (Visual Analog Scale - VAS), dyspnea score (0-10), ease of getting out of bed (0-10), need for ketorolac analgesia, treatment failure (requiring VATS within 7 days), 30-day rehospitalization, and complications. RESULTS: Forty patients (mean age 31.1±7.0 years; 80% male) were randomized to separate groups (20 per group). Baseline characteristics were similar between groups. The mean time to return to normal activities was significantly shorter in the Heimlich group (7.1±5.4 days vs. 10.2±8.0 days, P=0.014). Mean length of hospital stay was 5.6±3.0 days (Heimlich) vs. 7.3±4.6 days (Bottle), (P=0.081). Pain scores were significantly lower in the Heimlich group on days 1-4 (P<0.01). Ketorolac use (frequency and total dose) was significantly lower in the Heimlich group (P<0.001). Ease of getting out of bed was significantly greater in the Heimlich group throughout the assessment period. Pneumothorax resolution trended faster in the Heimlich group (P=0.077 on day 4). Dyspnea trended lower in the Heimlich group on day 4 (P=0.078). Treatment failure (requiring VATS) occurred in 1 (5%) of the Heimlich patients versus 3 (15%) of the Bottle patients (P = 0.29). Rehospitalization occurred in one patient per group (5%, P = 1.00). CONCLUSION: In patients with PSP, management with a Heimlich valve resulted in a significantly faster return to normal activities, lower pain scores, reduced analgesic requirements, and greater ease of mobilization than standard chest tube drainage. While not statistically significant, trends suggested faster pneumothorax resolution and potentially shorter hospital stays. The Heimlich valve appears to be a safe and effective alternative, offering potential patient comfort and recovery benefits. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT): IRCT20230208057359N1.