Cohort 2 Efficacy of Nasopharyngeal Ventilation With Endotracheal Tube for Patients With Predicted Difficult to Mask Ventilate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Tidal volume
研究概览
简要总结
Failed mask ventilation poses an increased risk of de-oxygenation to the patient undergoing general anesthesia. Nasopharyngeal ventilation may be a valid alternative for mask ventilation allowing for better oxygenation during the induction phase of general anesthesia. Oxygenation may be maintained better in case of difficult mask ventilation. This study evaluates this alternative method in comparison with the standard method of mask ventilation.
General Design This is a randomized, controlled, cross over study. Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or vice versa.
Primary Study Endpoints We will test the hypothesis that ventilation via a nasally placed ETT is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in patients undergoing general anesthesia and endotracheal intubation for their surgery.
详细描述
General Design This is a randomized, controlled, cross over study. Patients will be randomized to mask ventilation followed by nasopharyngeal airway placement and ventilation or vice versa.
Primary Study Endpoints In cohort 2 we will test the hypothesis that ventilation via a nasally placed ETT is superior in its efficacy (as measured by tidal volume) to routine facemask ventilation in patients undergoing endotracheal intubation for general anesthesia. In cohort 1 the patient population was restricted to patients undergoing oto-laryngologic or oral maxillofacial surgery that required nasal intubation.
Subject Selection and Withdrawal General Characteristics of the Proposed Subject Population
Subjects will be enrolled at the University Pre-Op clinic or the University Pre-Op holding area. There is no data indicating that ethnicity affects airway management. We accordingly will accept patients from all minority groups. Based on the population of greater Louisville, we expect that 85% of the subjects will be Caucasian. We will include male and female patients in the study.
Anticipated Number of Research Subjects In cohort two we are planning to enroll 20 patients scheduled for endotracheal intubation and general anesthesia with their surgery. Patients will qualify for enrollment in the study if they meet the inclusion criteria as defined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Subjects undergoing general anesthesia and require endotracheal intubation.
- •Adults patients 18 years or greater
- •Subjects are capable of understanding and signing the Informed Consent Form or have an acceptable representative capable of giving legally authorized consent on their behalf.
- •Meet three or more of predictive difficult to mask criteria as listed:
- •Age = or > than 55
- •BMI = or > than 30
- •History of snoring and/or a diagnoses of obstructive sleep apnea
- •STOP/BANG score of three or greater
- •Presesnce or a beard or mustach that covers the part of the face in conntact with the facemask edges
- •Male gender
- •History of neck radiation
- •Mallampati score of III or IV
排除标准
- •Subjects will be excluded from this study in cases where there will not be an attempt at mask ventilation. This includes patients that will require an awake fiberoptic intubation as well as those needing a rapid sequence intubation.
- •Subjects with full stomachs, known hiatal hernia, and severe gastroesophageal reflux will be excluded.
- •Subjects with known or suspected basilar skull fractures will be excluded.
结局指标
主要结局
Tidal volume
时间窗: 15 minutes
After facemask or nasopharyngeal ventilation
次要结局
- Airway pressure(3 min after facemask or nasopharyngeal ventilation)
研究者
Rainer Lenhardt
Associate Professor
University of Louisville