Lung Cancer PatientSuction48NCT07527702
Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection
A study testing Low-pressure digital suction (-4 cmH₂O) in people with Lung Cancer Patient, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Cancer Patient
- What is being tested?
- Low-pressure digital suction (-4 cmH₂O)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
In Kyu Park, MD,PHD, 82)+10-3783-2653, ikpark@snu.ac.kr
About this study
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
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:
Read more
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
- Being tested
- Low-pressure digital suction (-4 cmH₂O)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-pressure digital suction (-4 cmH₂O) | Experimental | Thopaz portable digital suction system - Low-pressure (-4 cmH₂O) Receives: Device: Low-pressure digital suction (-4 cmH₂O) |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
Chest tube duration (days)
Number of calendar days the chest tube remains in place during the index hospitalization.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start3 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer PatientStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Kyu Park, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527702
- Sponsor's protocol ID
- 2507-104-1658
- Other IDs
- 04-2025-0420
- Acronym
- Suction48
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07527702
- Acronym / sponsor ID
- Suction48 / 2507-104-1658
- Conditions
- Lung Cancer Patient
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-pressure digital suction (-4 cmH₂O) | Experimental | Device: Low-pressure digital suction (-4 cmH₂O)Thopaz portable digital suction system - Low-pressure (-4 cmH₂O) |
| 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Low-pressure digital suction (-4 cmH₂O) |
Primary outcome
Duration of postoperative air leak (days)
Time frame: 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.
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.
1 secondary outcome
Chest tube duration (days)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-pressure digital suction (-4 cmH₂O) in people with Lung Cancer Patient, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SeonYong Bae, MD (82) + 010-3205-4460, bsy115s@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative air leak (days) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.