Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection (Suction48)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Patient
• Intervention / Treatment: Device: Low-pressure digital suction (-4 cmH₂O)

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SeonYong Bae, MD; Phone Number: 82) + 010-3205-4460; Email: bsy115s@naver.com

Study Locations

• South Korea
  • Seoul, South Korea
    • Recruiting
    • Seoul National University Hospital
    • Contact: In Kyu Park, MD,PHD; Phone Number: 82)+10-3783-2653; Email: ikpark@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-pressure digital suction (-4 cmH₂O); Thopaz portable digital suction system - Low-pressure (-4 cmH₂O)	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.
No Intervention: Physiologic-pressure digital suction (-8 cmH₂O); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2507-104-1658; 04-2025-0420 (Other Grant/Funding Number: Seoul National University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No