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临床试验/NCT03571854
NCT03571854Unknown不适用

Comparison of Pressure-controlled Ventilation-volume Guaranteed Mode With Volume Controlled Ventilation in Prone Position During Lumbar Spine Surgery.

Hallym University Medical Center1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
Peak airway pressure

研究概览

简要总结

The anesthetized patient is turned to the prone position during lumbar spine surgery. The dynamic compliance of lung usually decreases and peak airway pressure increases during the surgery.

A new ventilation mode, pressure-controlled ventilation with volume guaranteed mode (PCV-VG) has been recently introduced. The ventilator compares the tidal volume of the previous breath and automatically regulates the pressure up or down to achieve the set tidal volume.

This prospective, randomized study is designed to compare the effect of PCV-VG and volume-controlled ventilation (VCV) on peak airway pressure, lung compliance and hemodynamic variables.

详细描述

  1. Total 34 patients with American Society of Anesthesiologists physical status I-III who underwent lumbar spine surgery in prone position were enrolled.
  2. All patients fasted for 8 hours before the surgery and were premedicated with intramuscular glycopyrrolate 0.2 mg. Anesthesia was induced with remifentanil (0.1-0.2 ug/kg/min), propofol (1.5-2 mg/kg) and rocuronium (0.6 mg.kg) and maintained with sevoflurane (2.0-2.5 vol%) in inspired oxygen fraction with 0.5, remifentanil (0.05-0.3 ug/kg/min) and vecuronium (0.03-0.05 mg/kg/hr).
  3. A 20 G catheter was inserted into the radial artery to monitor continuous arterial pressure and hemodynamic variables (cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) monitoring.
  4. All patients were ventilated with a Datex-Ohmeda Ventilator (S/5 AVANCE). Patients were randomized to receive either PCV-VG (n=17) or VCV (n=17) mode. The tidal volume in both group were set to deliver 8 mL/kg of ideal body weight. The respiratory rate (RR) was adjust to maintain end tidal CO2 (ETCO2) 33-38 mmHg.
  5. Hemodynamic variables (mean blood pressure, heart rate, cardiac output, cardiac index, stroke volume, stroke volume index, and stroke volume variation) , respiratory variables (saturation, RR, ETCO2, peak airway pressure, mean airway pressure and lung dynamic compliance) and arterial gas analyses were recorded at 4 stages: (1) 15 minutes after induction in supine position, (2) 30 minutes after turning the patient to the prone position, (3) 60 minutes after turning the patient to the prone position, (4) 15 minutes after turning the patient to supine position at the end of surgery.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were scheduled for lumbar spine surgery with the prone position
  • American Society of Anesthesiologists physical status I-III

排除标准

  • Age under 20 years old or over 70 years old
  • Body mass index > 30 kg/m2
  • Systolic blood pressure < 100 mmHg
  • Heart rate < 60 bpm
  • Uncompensated cardiac disease
  • FEV1 < 60%
  • Hypoxemia (PaO2 < 60 mmHg or oxygen saturation < 90%)

研究组 & 干预措施

Group PCV-VG

Experimental

Pressure controlled ventilation-volume guaranteed

干预措施: Group PCV-VG (Device)

Group VCV

Active Comparator

Volume controlled ventilation

干预措施: Group VCV (Device)

结局指标

主要结局

Peak airway pressure

时间窗: About 2-3 hours through the surgery

The highest level of pressure applied to the lungs during inhalation

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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