跳至主要内容
临床试验/NCT03148262
NCT03148262已完成不适用

Use of High-Flow Nasal Cannula to Prevent Desaturation Episodes in the Morbidly Obese Patients Undergoing Colonoscopy:A Prospective Randomized Clinical Trial

University of Texas Southwestern Medical Center4 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2017年5月10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
59
试验地点
4
主要终点
The Number of Desaturation Episodes

研究概览

简要总结

It is standard practice in the United States and many parts of world to perform Gastrointestinal (GI) endoscopy with the patient under deep sedation. Obesity is accepted as a patient specific risk factor for hypoxic events during procedural sedation for GI endoscopic procedures. The Obese population has a higher prevalence of obstructive sleep apnea (OSA) which is characterized by repeated obstruction of the upper airway, and leads to apnea and desaturation. This prospective, randomized study was designed to compare the effectiveness of the high flow nasal cannula and the standard nasal cannula in morbidly obese (BMI > 40) patients receiving deep intravenous sedation during colonoscopies. This study will assess whether use of the high flow nasal cannula (HFNC) leads to less intraoperative desaturation events compared to the current standard of care.

详细描述

The prevalence of morbid obesity is increasing worldwide. As the severity of obesity increases, the incidence of diagnosed obstructive sleep apnea also rises. Studies have shown an incidence of sleep apnea as high as 64% in patients with a body mass index (BMI) over 40 and 100% in patients with a BMI greater than 60. Patients with OSA have been shown to have significant desaturations under intravenous sedation due to airway narrowing and obstruction. Several studies have also shown that morbidly obese subjects, independent of a diagnosis of OSA, run a higher perioperative risk of adverse airway events, including hypoxia.

Many morbidly obese subjects present to our institution for GI procedures under deep sedation. Providing anesthesia for this patient population is challenging and requires careful titration of drugs and superb airway management skills. The current standard of care for oxygen delivery in this setting is a Salter nasal cannula. There are no prospective, randomized studies that compare the use of a high flow humidified nasal cannula system and standard nasal cannula in morbidly obese patients presenting for colonoscopy under anesthesia.

Humidified high flow nasal cannula (HFNC) oxygen therapy utilizes an air oxygen blend allowing from 21% to 100% FiO2 delivery and generates up to 60 L/min flow rates. The gas is heated (35 to 40 degree Celsius) and humidified through an active heated humidifier and delivered via a single limb heated inspiratory circuit (to avoid heat loss and condensation) to the subject through a large diameter nasal cannula. Theoretically, HFNC offers significant advantages in oxygenation and ventilation over conventional methods (9). Constant high flow oxygen delivery provides steady inspired oxygen fraction (FiO2) and decreases oxygen dilution. It also washes out physiologic dead space and generates positive end expiration pressure (PEEP) that augments ventilation. In the current narrative review, Sotello et al. summarized factors explained the improvement in respiratory parameters by using HFNC. (1) Washout of the nasopharyngeal dead space; (2) Reduction in inspiratory resistance associated with gas flow through the nasopharynx; (3) Improvement in respiratory mechanical parameters associated with gas temperature and state of humidification; (4) Reduction in metabolic work associated with gas conditioning; (5) Provision of mild distending pressure.

Some studies have demonstrated a positive effect of HFNC on the apnea-hypopnea index (AHI) showing that use of HFNC could decrease hypoxic episodes in subjects with repetitive upper airway obstruction such as obstructive sleep apnea. The STOP-BANG questionnaire (SB) has been used successfully to screen patients undergoing therapeutic endoscopic procedures at higher risk for sedation-related adverse events.

We are hypothesizing that the HFNC will help maintain a patent airway and improve gaseous exchange in the morbidly obese patients undergoing deep sedation for colonoscopies and will result in a significant decrease in intraoperative desaturation events, thus improving morbidity and overall safety for this subgroup.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-80
  • Subjects undergoing colonoscopies
  • Morbidly obese BMI ≥ 40

排除标准

  • Subjects deemed hemodynamically unstable by the anesthesia team
  • Subjects who are an aspiration risk and will require endotracheal intubation.
  • Pregnancy
  • Subjects with an allergy to propofol
  • Patients who are unable to tolerate the high flow nasal cannula secondary to discomfort
  • Subjects unwilling to sign consent
  • Chronic obstructive pulmonary disease
  • Patients that received medications other than lidocaine and propofol

研究组 & 干预措施

The high flow nasal cannula

Experimental

The Comfort Flo system will be used for the high flow nasal cannula during colonoscopy

干预措施: The Comfort Flo system (Device)

The standard nasal cannula

Placebo Comparator

The Salter nasal cannula will be used during the colonoscopy

干预措施: The Salter nasal cannula (Device)

结局指标

主要结局

The Number of Desaturation Episodes

时间窗: Perioperative period during colonoscopy

The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Riccio

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (4)

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