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临床试验/NCT03804398
NCT03804398已完成不适用

Effect of Compliance Guided an Optimal Positive End-Expiratory Pressure on Arterial Oxygenation and Intrapulmonary Shunt During One-lung Ventilation

Fujian Medical University Union Hospital1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
arterial oxygenation

研究概览

简要总结

To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure(PEEP)on arterial oxygenation and intrapulmonary shunt during one-lung ventilation(OLV),and discuss the lung protective effect of optimal PEEP during one-lung ventilation.

详细描述

Sixty patients undergoing thoracic surgery were randomly allocated to the study or control group.Patients were monitored for electrocardiogram, pulse oximetry, and non-invasive blood pressure,20 gauge cannula needle for radial artery catheterization under local anesthesia, monitoring ABP.,the right subclavian vein was selected for catheterization under local anesthesia,monitoring CVP.Anesthesia was induced with sufentanil 0.4 μg/kg, propofol 2 mg/kg, and cisatracurium 0.3 mg/kg.The trachea was intubated with a double-lumen tube (DLT),37F for male and 35F for female patients.Tube position was confirmed by bronchoscopy in the supine and lateral positions.Anesthesia was maintained with sevoflurane 1.0-1.5 vol%,propofol 2-4 mg/(kg·h) and remifentanil 0.1-0.2 μg/(kg·min) and intermittent cisatracurium 0.06-0.1 mg/kg.The lungs were initially ventilated using a volume-controlled ventilation mode,two-lung ventilation(TLV):tidal volume (VT) 8 ml/kg,respiratory rate 12-14 bpm, inspiratory:expiratory (I:E) ratio 1:2, in 60% oxygen without PEEP. During OLV, VT was reduced to 6 ml/kg,OLV was initiated at the moment of skin incision.Both groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.In the control group at PEEP level of 5 cmH2O was established and maintained during the study period.Blood gas analyses, respiratory variables, and hemodynamic variables were recorded at 6 different time points:10 min after TLV(T0), 10min after OLV(T1), 30min after PEEP(T2), 60min after PEEP(T3), 10min after the end OLV(T4) and 20min after extubation(T5).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 yr to 65 yr
  • Body mass index(BMI)18-28kg/m2
  • American Society of Anesthesiologists Physical Status Classifications I to II
  • Normal cardiac and pulmonary function
  • Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia.

排除标准

  • Forced expiratory volume at one second/forced vital capacity <70%
  • Chronic obstructive pulmonary disease
  • Acute lung infection
  • Past history of thoracic surgery
  • Cardiac,hepatic,renal and endocrine diseases
  • Preoperative glucocorticoid medication
  • Preoperative chemotherapy
  • Peripheral oxygen saturation(SpO2) kept below 90% for more than 10 minutes during operation
  • Blood transfusion during operation
  • Duration of one-lung ventilation less than an hour
  • Occurrence of severe complications like allergic shock

研究组 & 干预措施

optimal PEEP group

Experimental

The study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained

干预措施: compliance guided an optimal Positive End-Expiratory Pressure (Device)

PEEP level of 5 cmH2O group

Active Comparator

In the control group at PEEP level of 5 cmH2O was established and maintained during the study period

干预措施: PEEP level of 5 cmH2O (Device)

结局指标

主要结局

arterial oxygenation

时间窗: 24 hours

To observe the effect of compliance guided an optimal Positive End-Expiratory Pressure(PEEP)on arterial oxygenation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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