Lower (-4 cmH₂O) versus standard (-8 cmH₂O) digital chest 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

This trial tests whether using a lower negative pressure (-4 cmH₂O) on a digital chest drainage device after segmentectomy or lobectomy for lung cancer helps get the chest tube out sooner than the usual -8 cmH₂O.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT07527702 on ClinicalTrials.gov

What this trial studies

This randomized interventional study enrolls adults undergoing anatomical lung resection (segmentectomy or lobectomy) for confirmed or suspected primary lung cancer at Seoul National University Hospital and uses a Thopaz digital continuous suction device as the sole chest drain. Patients with a measurable air leak on postoperative day 1 are randomized to continuous suction set at either -4 cmH₂O or -8 cmH₂O. The primary outcome is duration of chest tube placement; secondary outcomes include air-leak duration, length of hospital stay, postoperative complications (pneumothorax, subcutaneous emphysema, re-intervention), need for pleurodesis or suction readjustment, and 30-day readmission. Patients without a clinically meaningful air leak on POD1 are considered screen failures and are not randomized.

Who should consider this trial

Good fit: Adults aged 19 or older undergoing lobectomy or segmentectomy for confirmed or suspected primary lung cancer who have a measurable air leak on postoperative day 1 and have a Thopaz digital drainage device as the sole chest drain.

Not a fit: Patients without a measurable air leak on POD1, those who require two or more drains, those who experience immediate postoperative ICU-level complications, or those whose drainage system is changed before randomization are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, using lower suction could shorten chest tube duration and hospital stay without increasing postoperative complications.

How similar studies have performed: Some prior observational studies and device reports suggest suction level can affect air-leak behavior, but randomized direct comparisons between -4 and -8 cmH₂O are limited, so this specific comparison is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Adults ≥19 years of age.
* Undergoing anatomical lung resection (segmentectomy or lobectomy) for confirmed or suspected primary lung cancer at a tertiary center.
* Digital continuous suction device (Thopaz) used as the sole chest drainage system immediately after surgery.
* Able to provide written informed consent on the day before surgery.
* Randomization criterion (in-hospital): On postoperative day 1 (approximately 7-8 AM), a measurable air leak persists and the chest tube is not removed per routine care. Participants with no clinically meaningful air leak on POD1 (e.g., 0-10 mL/min per institutional criteria) will be considered screen failures and will not be assigned to an arm.

Exclusion Criteria:

* Placement of two or more drains (e.g., additional chest tube or JP drain) during the index surgery.
* Intraoperative or immediate postoperative serious complication requiring ICU care.
* Change from the digital suction system to another drainage system prior to randomization or outcome assessment.
* Any condition that, in the opinion of the investigator, makes participation inappropriate (e.g., inability to comply with study procedures or safety concerns).

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: SeonYong Bae, MD

Conditions: Lung Cancer Patient