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临床试验/NCT06847412
NCT06847412进行中(未招募)不适用

Comparative Study of Escalating PEEP (Positive End Expiratory Pressure) Vs. Lung Recruitment by Sustained Inflation Strategies for Managing Hypoxemia in COPD Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Incidence of ICU admission

研究概览

简要总结

This study evaluates and compares the effectiveness of two distinct ventilation strategies-escalating PEEP and lung recruitment maneuvers-in improving oxygenation (i.e., managing hypoxemia) in COPD patients undergoing VATS.

详细描述

A) Preoperative settings :

  • Written informed consent will be obtained from all participants prior to the study.

  • Pre-operative optimisation of patients include cessation of smoking, improvement of pulmonary functions using bronchodilators and steroids, pre-operative chest physiotherapy and training of patient with lung expansion manuoevers. Reversible components of COPD such as bronchospasm, infections, and pulmonary oedema should be actively looked for and treated aggressively 9.

  • Detection of severity of COPD by using The Global Initiative for Chronic Obstructive Lung Disease (GOLD) system categorizes airflow limitation into stages. In patients with FEV₁/FVC <0.7:

  • GOLD 1 - mild: FEV₁ ≥80% predicted

  • GOLD 2 - moderate: 50% ≤ FEV₁ <80% predicted

  • GOLD 3 - severe: 30% ≤ FEV₁ <50% predicted

  • GOLD 4 - very severe: FEV₁ <30% predicted 10.

  • Preoperative assessment evaluates lung mechanics, parenchymal function, and cardiopulmonary reserve to determine a patient's suitability for surgery. Lung mechanics, including forced expiratory volume in 1 second (FEV1), maximum voluntary ventilation, forced vital capacity, and residual volume/total lung capacity (RV/TLC) ratio, provide insights into respiratory function. An FEV1 greater than 60% indicates potential tolerance for anatomic lobe resection. An FEV1 of less than 30% suggests postoperative ventilator or supplemental oxygen dependence. In FEV1s less than 60%, a ventilation-perfusion scan (VQ scan) may calculate a postoperative FEV1, with values above 35% (and up to 40%), suggesting adequate postoperative pulmonary reserve. DLCO, measuring gas diffusion, ideally exceeds 40% for surgery. Cardiopulmonary exercise testing assesses overall reserve, with a maximum rate of oxygen (O2) your body can use during exercise (VO2) greater than 10 mL/min/kg, indicating suitability for surgery 2.

  • Preoperative assessment for VATS also involves evaluating blood counts for indications of polycythemia or infection. Chest x-rays and CT scans provide anatomical details for surgical planning. Arterial blood gases identify patients at risk for postoperative complications; a partial pressure of carbon dioxide (CO2) more than 50 mm Hg or a partial pressure of O2 less than 60 mm Hg indicates vulnerability 2.

B) Intraoperative settings:

Electrocardiogram (ECG), non-invasive blood pressure (NIBP), pulse oximeter (SpO2) will be applied, and baseline readings will be taken before induction.

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)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥ 20 years and </=60 years.
  • •Both sex.
  • •Patients American Society of Anesthesiologists Physical Status (ASA) Il to IIl.
  • •A written, valid, and informed consent
  • •Mild to moderate COPD patients
  • •BMI less than 4

排除标准

  • •Patient refusal.
  • •Pregnancy
  • •VATS procedure converted to open thoracotomy
  • •Patients have other lung diseases
  • •Patients ASA more than lll
  • •Patients with cardiac diseases affecting systolic & diastolic functions

研究组 & 干预措施

Group (A): Escalating PEEP

Active Comparator

This group will undergo VATS & one hypoxemia started PEEP is typically increased in 2-3 cm H₂O increments while monitoring the patient's response (oxygenation, hemodynamics, and lung compliance).

干预措施: Escalating PEEP (Device)

Group (B): Lung recruitment by Sustained inflation

Active Comparator

A sustained inflation:

Set the ventilator to CPAP mode and increase the pressure to 30 cm H2O for 30 s.

干预措施: Sustained inflation (Device)

结局指标

主要结局

Incidence of ICU admission

时间窗: 6 months

The incidence of post-operative patients requiring ICU admission

次要结局

  • Incidence of pulmonary complications(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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