NCT07527702

Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection

Efficacy and Safety of Low Pressure (-4cmH2O) Suction Compared With Physiologic Pressure (-8cmH2O) Suction Using Digital Continuous Suction System After Pulmonary Resection: A Prospective Randomized Controlled Open-label Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn whether using a lower negative pressure (-4 cmH₂O) on a digital chest drainage device after lung resection reduces the time a chest tube must stay in place compared with the commonly used physiologic pressure (-8 cmH₂O), without increasing complications. The trial enrolls adult patients undergoing segmentectomy or lobectomy for lung cancer at a tertiary medical center. The main questions it aims to answer are: Does the -4 cmH₂O setting shorten chest tube duration (primary outcome) compared with -8 cmH₂O? What is the effect of -4 vs -8 cmH₂O on air-leak duration, length of hospital stay, and postoperative complications (e.g., pneumothorax, subcutaneous emphysema, re-intervention), and on the need for pleurodesis or suction readjustment, and 30-day readmission? Researchers will compare patients assigned to -4 cmH₂O with patients assigned to -8 cmH₂O to see whether the lower pressure improves recovery after lung resection. The trial is prospective, randomized, open-label (two parallel arms; planned sample size \~160; 1:1 allocation). An interaction analysis will also explore whether effects differ between patients with lower vs higher air-leak flow on postoperative day (POD) 1. Participants will: Receive standard perioperative care for lung resection. Provide written informed consent on the day before surgery following a discussion with study staff. On POD#1 (approximately 7-8 AM), have air-leak flow measured by the digital device. If no clinically meaningful air leak is present on POD#1 (e.g., 0-10 mL/min by institutional criteria) and the chest tube is likely to be removed, the participant will not be randomized and will continue standard care outside the comparative analysis (screen fail/observational record only). If an air leak persists on POD#1, the participant will be randomized to -4 or -8 cmH₂O suction and the assigned setting will be maintained until chest tube removal, unless a clinical safety reason requires adjustment. Undergo routine inpatient assessments already used in standard care (e.g., daily chest X-rays, recording of air-leak flow and drainage volume, monitoring for complications) until discharge. The study uses a commercially available digital chest drainage system already employed in routine practice. Because it is open-label, neither clinicians nor participants are blinded to the pressure setting. If predefined safety signals occur (e.g., clear increases in complications or prolonged air leaks in one arm), the protocol allows suction adjustment for individual safety and interim review for potential early stopping, in accordance with institutional policies.

Conditions

• Lung Cancer Patient

Interventions

Type	Name	Description
DEVICE	Low-pressure digital suction (-4 cmH₂O)	A digital thoracic drainage device set to continuous suction at -4 cmH₂O, initiated on postoperative day 1 after randomization. The assigned suction pressure is maintained until chest tube removal unless predefined clinical safety criteria require adjustment. Air-leak flow and drainage volume are recorded as part of routine postoperative care.

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: South Korea