One-lung Ventilation With Double-Lumen Tubes and Bronchial Blockers in Obese Patients Undergoing Lung Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Hypoxia
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of bronchial blockers and double-lumen tubes in achieving one-lung ventilation in obese patients undergoing lung resections. The primary question it aims to answer is:
• Is intraoperative hypoxia significantly different depending on the device used?
Researchers will compare the use of bronchial blockers and double-lumen tubes to assess differences in efficacy and safety.
Participants will not be required to perform any tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patients do not know which device will be used during their surgery, as is typical in routine clinical practice.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 kg/m2
- •Diagnostic or clinical suspicion of lung cancer
- •Lung resection surgery (lobectomy, segmentectomy or wedge resection) by VATS or thoracotomy, requiring one-lung ventilation.
- •Use of bronchial blocker or double-lumen tube for one-lung ventilation.
排除标准
- •Patients with evident anatomic alterations, in which double-lumen tubes may be contraindicated.
- •Emergency surgeries.
结局指标
主要结局
Hypoxia
时间窗: Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation)
While its definition is somewhat arbitrary, the investigators consider hypoxia as SpO₂ \< 90%, while maintaining FiO₂ = 1.0, in accordance to our hospital guidelines.
次要结局
- Lung collapse(Intraoperative)
- Surgical visualization(Intraoperative)
- Insertion time of the ventilation device(Intraoperative)
- Repositioning of the ventilation device(Intraoperative)
- Ventilation device change(Intraoperative)
- Techniques employed in case of hypoxia(Intraoperative)
- SpO₂(Preoperative and intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Ventilation mode(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Tidal volume (Vt)(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Respiratory Rate (Fr)(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Peak Airway pressure(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Plateau Pressure(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Driving Pressure(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Fraction of Inspired Oxygen (FiO₂)(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Partial Pressure of Arterial Oxygen (PaO₂)(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Partial Pressure of Arterial Carbon Dioxide (PaCO₂)(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- PaO₂/FiO₂(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Hemoglobin(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Hematocrit(Intraoperative (both from anesthetic induction to one-lung ventilation, and during one-lung ventilation))
- Intraoperative complications(Intraoperative)
- Postoperative recovery complications(First 24 hours after surgery)
研究者
Paulo Andrés Cano Jiménez
Principal Investigator
Hospital Son Espases