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临床试验/NCT07729319
NCT07729319招募中不适用

Clinical Effects of Active Versus Passive Intraoperative Respiratory Gas Humidification During Video-Assisted Thoracoscopic Surgery: A Prospective Single-Center Observational Cohort Study

Marmara University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年7月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Incidence of Postoperative Pulmonary Complications

研究概览

简要总结

General anesthesia with endotracheal intubation bypasses the physiological warming and humidification functions of the upper airway, allowing cold and dry gases to reach the lower respiratory tract. This may impair mucociliary clearance, increase secretion viscosity, promote atelectasis, and contribute to postoperative pulmonary complications (PPCs).

Patients undergoing thoracic surgery, particularly those requiring one-lung ventilation (OLV), are at increased risk for PPCs because of altered ventilation-perfusion matching, reduced functional residual capacity, and impaired secretion clearance. Although respiratory gas humidification is routinely used during anesthesia, evidence regarding the comparative clinical effects of active heated humidification (AHH) and passive heat and moisture exchangers (HMEs) during thoracic surgery remains limited.

This prospective observational cohort study aims to evaluate the association between intraoperative respiratory gas humidification methods and postoperative pulmonary complications and perioperative clinical outcomes in adult patients undergoing elective video-assisted thoracoscopic surgery (VATS).

详细描述

The physiological conditioning of inspired gases is bypassed during general anesthesia with endotracheal intubation. Delivery of inadequately heated and humidified gases to the lower respiratory tract may impair mucociliary function, increase secretion viscosity, reduce airway patency, and promote postoperative pulmonary complications.

Patients undergoing video-assisted thoracoscopic surgery (VATS) frequently require one-lung ventilation, which further increases susceptibility to pulmonary complications through ventilation-perfusion mismatch, impaired secretion clearance, and atelectasis formation.

Two principal approaches are used for intraoperative respiratory gas conditioning:

Passive heat and moisture exchangers (HMEs) Active heated humidification systems (AHHs) Although HMEs are widely used because of their simplicity, they may provide insufficient humidification during prolonged procedures, high minute ventilation, or one-lung ventilation. Active heated humidifiers deliver gases closer to physiological conditions (approximately 37°C and 100% relative humidity), potentially reducing secretion viscosity and improving airway patency.

Most existing studies evaluating respiratory gas humidification have focused on intensive care patients receiving prolonged mechanical ventilation. Evidence regarding thoracic surgical patients remains limited, particularly during one-lung ventilation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 75 years
  • Elective video-assisted thoracoscopic surgery (VATS)
  • Lung resection requiring general anesthesia
  • Planned one-lung ventilation
  • Written informed consent

排除标准

  • Emergency surgery
  • Pregnancy
  • Preoperative mechanical ventilation
  • Previous enrollment
  • Refusal to participate

结局指标

主要结局

Incidence of Postoperative Pulmonary Complications

时间窗: From completion of surgery through postoperative Day 7.

Incidence of one or more postoperative pulmonary complications occurring within 7 days after surgery, including atelectasis, pneumonia, secretion retention, bronchoscopy for mucus plugging, prolonged oxygen requirement, requirement for non-invasive or invasive ventilatory support, or reintubation. PPCs will be assessed using predefined clinical and radiological criteria.

次要结局

  • Oxygenation (PaO₂/FiO₂ Ratio)(Measured during one-lung ventilation and at the end of surgery.)
  • Frequency of Endotracheal Suctioning(From induction of anesthesia until completion of surgery.)
  • Airway Secretion Viscosity Score(During one-lung ventilation, at the end of one-lung ventilation, and within 24 hours after extubation.)
  • Incidence of Intraoperative Hypothermia(From induction of anesthesia until completion of surgery.)
  • Incidence of Postoperative Hypothermia(Within the first 24 hours after surgery.)
  • Postoperative Oxygen Therapy Requirement(Within the first 72 hours after surgery.)
  • Requirement for Non-invasive Ventilation(Within the first 72 hours after surgery.)
  • Intensive Care Unit Length of Stay(From ICU admission until ICU discharge, up to postoperative Day 30.)
  • Hospital Length of Stay(From surgery until hospital discharge, up to postoperative Day 30.)
  • Bronchodilator Therapy Requirement(Within 7 days after surgery.)
  • C-Reactive Protein (CRP)(Postoperative Day 7.)

研究者

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

Ulgen Zengin

Associate Professor of Anesthesiology, Principal Investigator

Marmara University

研究点 (1)

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