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EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode (EPO2-PV)

2017年9月14日 更新者:Jean Bussières、Laval University

Evaluation of Different Pre-Oxygenation Conditions in Morbid Obesity: Position and Ventilation Mode, in a Respiratory Physiology Laboratory, on Voluntary Subjects

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature.

This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

研究概览

详细说明

Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes.

Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight.

The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume.

Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique.

We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.

研究类型

介入性

注册 (实际的)

20

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。

学习地点

    • Quebec
      • Quebec city、Quebec、加拿大、G1V4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec

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

21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:

  • BMI 40 - 80 kg / m2
  • Waist circumference: Men: More than 130 cm
  • Waist circumference: Women: More than 115 cm

Exclusion Criteria:

  • Facial hair
  • Cranio-facial abnormality
  • Claustrophobia
  • Asthma
  • COPD (defined by FEV1 < 80 %)
  • Severe cardiovascular disease (defined by NYHA ≥3)
  • Pregnancy
  • Tobacco use
  • NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).

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:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Supine
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.
实验性的:Beach-chair (Back : 25 deg)
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.
实验性的:Proclive (Global 25 deg)
NIPPV and Tidal volume

Ventilation: non-invasive positive pressure ventilation (NIPPV)

Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)

Tidal volume spontaneous ventilation, no assistance.

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
Functional Residual Capacity
大体时间:After a 5 minutes pre-oxygenation period
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.
After a 5 minutes pre-oxygenation period

次要结果测量

结果测量
措施说明
大体时间
Diaphragmatic Amplitude.
大体时间:After a 5 minutes pre-oxygenation period
Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
After a 5 minutes pre-oxygenation period
Respiratory Mechanics
大体时间:At the end of a 5 minutes pre-oxygenation period
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period
Patient's Comfort
大体时间:At the end of a 5 minutes pre-oxygenation period
Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period

其他结果措施

结果测量
措施说明
大体时间
Vital Signs
大体时间:At the end of a 5 minutes pre-oxygenation period
Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
At the end of a 5 minutes pre-oxygenation period

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。

调查人员

  • 首席研究员:Etienne J Couture, MD、Laval University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2014年4月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2014年4月22日

首先提交符合 QC 标准的

2014年4月23日

首次发布 (估计)

2014年4月24日

研究记录更新

最后更新发布 (实际的)

2018年4月9日

上次提交的符合 QC 标准的更新

2017年9月14日

最后验证

2017年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • IUCPQ 21054

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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