Lower (-4 cmH₂O) versus standard (-8 cmH₂O) digital chest suction after lung resection
Official title: 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
Run by Seoul National University Hospital · NCT07527702 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | April 14, 2026 |
| Trial ID | NCT07527702 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Seoul National University Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: SeonYong Bae, MD
- Email: bsy115s@naver.com
- Phone: 82) + 010-3205-4460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.