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Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure During Mask Ventilation

2021年9月10日 更新者:Maha Mostafa Ahmad, MD、Kasr El Aini Hospital

Evaluation of Adequacy of Ventilation and Gastric Insufflation During Three Levels of Inspiratory Pressure for Pressure-controlled Mask Ventilation During Induction of Anesthesia: a Randomized Controlled Study

Pulmonary aspiration of gastric contents is one of the leading causes of general anesthesia-related mortality. Gastric insufflation during positive pressure mask ventilation increases the gastric volume, and consequently the risk of regurgitation. Thus, positive pressure mask ventilation should be avoided during rapid sequence induction of anesthesia when full-stomach is suspected (e.g. inadequate fasting hours, gastrointestinal obstruction, delayed gastric emptying, and lower esophageal disease) Although avoidance of positive pressure mask ventilation during induction would potentially minimize the risk of aspiration, this would lead to rapid hypoxia . Hence, finding a proper regimen for mask ventilation would avoid hypoxia which might be serious in high-risk patients.

Pressure-controlled face mask ventilation previously proved to be the least regimen to cause gastric insufflation in comparison to manual, and volume-controlled mask ventilation during induction of anesthesia. Later, a pressure of 15 cmH2O during face mask ventilation had been reported optimum to achieve the balance between adequate ventilation and reduced gastric insufflation in non-paralyzed patients. This finding was not yet replicated in paralyzed patients who represent the majority of population who receive mask ventilation during induction of anesthesia. We hypothesize that in paralyzed patient, the optimum pressure during face mask ventilation might be lower than the pressure which was previously reported in non-paralyzed patients. However, no studies to the best of our knowledge had confirmed this hypothesis.

Gastric insufflation was previously evaluated using auscultation with stethoscope, microphone placed in the epigastric area, or esophageal manometry. Recently, gastric antrum ultrasound was used successfully to gastric insufflation in real time by measuring the cross sectional area of gastric antrum before and after face mask ventilation. This newly developed method is more sensitive than the auscultatory method and less invasive than esophageal manometry method.

研究概览

详细说明

Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied, intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated. End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting face-mask ventilation. Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and rocuronium (0.6 mg/Kg). After loss of verbal response, mask ventilation will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and double hand jaw thrust head tilt maneuver. The included patients will be randomly allocated to receive the assigned pressure-controlled mask ventilation. The 3 study groups will receive the planned inspiratory pressure, without positive end-expiratory pressure, with a respiratory rate of 15, and inspiratory to expiratory ratio of 1:2 for 180 seconds.

Assessment gastric insufflation during mask ventilation will be achieved by ultrasound assessment of gastric antrum (in the sagittal plane between left lobe of the liver and pancreas at level of the aorta) and auscultation by two blinded investigators to the assigned pressure. The ultrasound screen will be positioned to be not visible to the investigator responsible for auscultation. Gastric insufflation will be identified by comet-tail sign by gastric ultrasound and gurgling sound by auscultation.

Gastric antrum cross sectional area [ D1(longitudinal diameter) X D2 (anteroposterior diameter) X π /4] in between contractions in supine position before face mask ventilation and after insertion of endotracheal tube will be recorded. gastric insufflation will be identified if gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline.

During mask ventilation, the following parameter will be recorded at 30, 60, 90,120, 150 and 180 seconds; peripheral oxygen saturation, the end-tidal carbon dioxide concentration , peak airway measured pressure, and tidal volume Demographic data (age, sex, weight, height, BMI, comorbidities) will be recorded.

研究类型

介入性

注册 (预期的)

111

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Cairo、埃及、11562
        • 招聘中
        • Kasr Alaini hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • adult patients (above 18 years)
  • American society of anesthesiologist I-II
  • scheduled for elective non-cardiac surgery under general anesthesia

Exclusion Criteria:

  • increased risk of difficult mask ventilation
  • patients at risk of aspiration
  • Patients with craniofacial anomalies
  • BMI >35 kg/m2
  • pregnant patients

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器:pressure 10
mask ventilation with peak inspiratory pressure of 10 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
有源比较器:pressure 15
mask ventilation with peak inspiratory pressure of 15 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
有源比较器:pressure 20
mask ventilation with peak inspiratory pressure of 20 cmH2O
pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
incidence of gastric insufflation by ultrasonography
大体时间:within 1 minute after endotracheal intubation
gastric antrum cross sectional area increased by > 30% after endotracheal intubation in relation to the baseline
within 1 minute after endotracheal intubation

次要结果测量

结果测量
措施说明
大体时间
Gastric antrum cross sectional area
大体时间:1 minute before mask ventilation and within 1 minute after endotracheal intubation
gastric antrum longitudinal diameter X anteroposterior diameter X π /4 in between contractions in supine position
1 minute before mask ventilation and within 1 minute after endotracheal intubation
tidal volume
大体时间:at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
mL
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
endtidal CO2
大体时间:at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
mmHg
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
peripheral O2 saturation
大体时间:at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
percentage
at 30, 60, 90,120, 150, and 180 seconds after onset of mask ventilation
incidence of gastric insufflation by auscultation
大体时间:1 minute after onset of mask ventilation
gurgling sound by stethoscope
1 minute after onset of mask ventilation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月9日

初级完成 (预期的)

2021年12月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2021年8月19日

首先提交符合 QC 标准的

2021年8月19日

首次发布 (实际的)

2021年8月25日

研究记录更新

最后更新发布 (实际的)

2021年9月13日

上次提交的符合 QC 标准的更新

2021年9月10日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • MD-250-2019

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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