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| ID | Type | Description | Link |
|---|---|---|---|
| 04-2025-0420 | Other Grant/Funding Number | Seoul National University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-pressure digital suction (-4 cmH₂O) | Experimental | Thopaz portable digital suction system - Low-pressure (-4 cmH₂O) |
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| Physiologic-pressure digital suction (-8 cmH₂O) | No Intervention | A digital thoracic drainage device set to continuous suction at -8 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-pressure digital suction (-4 cmH₂O) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative air leak (days) | Daily air-leak flow (mL/min) recorded by the digital chest drainage system (≈6 AM). Air-leak resolution is defined as no visible air leak or <10 mL/min sustained for ≥12 hours with adequate lung expansion on chest X-ray and stable clinical status. Duration is calculated in days from randomization (POD1) to resolution. | Time Frame: From postoperative day 1 randomization to the date of air-leak resolution, assessed daily, up to 30 days postoperatively or until hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube duration (days) | Number of calendar days the chest tube remains in place during the index hospitalization. | Time Frame: From the date of surgery to the date of chest tube removal, assessed during the index hospitalization for up to 30 postoperative days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SeonYong Bae, MD | Contact | 82) + 010-3205-4460 | bsy115s@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
No plan to share de-identified IPD due to institutional policy and/or consent constraints. Aggregate results will be published, and key study documents (e.g., protocol, SAP) may be made available upon reasonable request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2025 | Jan 21, 2026 | Prot_SAP_000.pdf |
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