跳至主要内容
临床试验/NCT07527702
NCT07527702招募中不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Duration of postoperative air leak (days)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Low-pressure digital suction (-4 cmH₂O)

Experimental

Thopaz portable digital suction system - Low-pressure (-4 cmH₂O)

干预措施: Low-pressure digital suction (-4 cmH₂O) (Device)

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.

结局指标

主要结局

Duration of postoperative air leak (days)

时间窗: 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.

次要结局

  • Chest tube duration (days)(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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

In Kyu Park

Professor

Seoul National University Hospital

研究点 (1)

Loading locations...

相似试验