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临床试验/NCT02859597
NCT02859597已完成不适用

Randomized. Controlled Trial of the Utilization of High Flow Nasal Cannula for Oxygenation of Sedated Morbidly Obese Patients in the Endoscopy Suite

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2016年12月28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
41
试验地点
1
主要终点
Ability to Maintain Oxygenation

研究概览

简要总结

This study evaluates the ability of high flow nasal cannula versus nasal cannula to oxygenate morbidly obese patients undergoing moderate to deep sedation for gastrointestinal procedures.

详细描述

The respiratory physiology of morbidly obese patients is altered due to restriction of the chest wall motion which decreases pulmonary compliance. In addition, anatomical changes lead to an increased incidence of airway obstruction in morbidly obese patients during periods of sedation. Both a typical nasal cannula and high flow nasal cannula provide supplemental oxygen to the patients to prevent desaturation and hypoxia. However, the higher flow rates of high flow nasal cannulas are able to produce allows for washout of carbon dioxide from the respiratory system aiding with ventilation and creates 3 to 5 cm H2O of positive end expiration pressure which helps prevent collapse of the airway aiding with oxygenation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • •Body Mass Index greater than or equal to 40
  • •Scheduled for a gastrointestinal endoscopy that requires MAC sedation

排除标准

  • •Body Mass Index less than 40
  • •Require either invasive or non-invasive ventilation for respiratory failure
  • •Use home oxygen
  • •Ventilation is via a tracheostomy
  • •The procedure is emergent

研究组 & 干预措施

High Flow Nasal Cannula

Experimental

High flow nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.

干预措施: High flow nasal cannula (Device)

Nasal Cannula

Active Comparator

Typical nasal cannula will be utilized to deliver oxygen to morbidly obese patients undergoing deep sedation for gastrointestinal procedures.

干预措施: Nasal Cannula (Device)

结局指标

主要结局

Ability to Maintain Oxygenation

时间窗: During the period of sedation, on average up to 1 hour

The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.

次要结局

  • Number of Participants Requiring Airway Adjuncts During Procedure(During the period of sedation, on average up to 1 hour)
  • Number of Participants Who Need an Increase in Fraction of Inspired Oxygen(During period of sedation, on average up to 1 hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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