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临床试验/NCT00581230
NCT00581230已完成不适用

An Evaluation Of The Rapid Airway Management Positioner (RAMP) In Obese Patients Undergoing Gastric Bypass Or Laparoscopic Gastric Banding (Lap-Band) Surgery

The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2007年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Ease of Mask Ventilation as Assessed by Han Class

研究概览

简要总结

The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP, AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric banding surgery.

详细描述

The cannot intubate, cannot ventilate case is the most dangerous of situations, and being able to foresee, prevent, and prepare for such difficulties is the task of every anesthesiologist. Difficult mask ventilation is predicted by a number of factors, including obesity.1 Appropriate bag-and-mask ventilation necessitates a patent airway. An increased BMI is associated with a reduced posterior airway space behind the tongue's base as well as a quick development of hypoxemia from reduced functional residual capacity in improper mask ventilation.1 Proper head and neck positioning to establish the patent airway then is especially important.

There is an increased risk of difficult laryngoscopy among obese patients compared with subjects with normal body mass index.2,3 Optimal laryngeal view during laryngoscopy can be facilitated with proper head and neck positioning, including slight elevation of the head, neck flexion relative to the chest, and extreme atlanto-occipital extension.4 The "ramped" position, where the patient's ear is horizontally aligned with their sternal notch, has been found to be superior to the standard "sniffing" position, 7-cm occiput elevation, during direct laryngoscopy in morbidly obese patients.4

Additionally, there are increased difficulties and risks for tracheal intubation in obese patients versus normal-weight patients. Studies have found that chances for a successful first attempt at oral intubation decrease as patient weight increases.6,7 Improving visualization of laryngeal structures will increase the likelihood of successful tracheal intubation, as increasing the percentage of glottic opening is correlated with the number of intubation attempts, as well as the need for rescue intubation devices.8

It is estimated that endotracheal intubation is performed on approximately 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. There is fairly uniform reporting of the incidence of failed intubation in the literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients.9,10 The incidence of unsuspected difficult intubation is estimated to be higher at 3%. One factor that contributes to difficult intubation is poor visualization, and difficult laryngoscopy is highly correlated with poor laryngeal exposure.11

The Rapid Airway Management Positioner (RAMP) is designed to optimize visualization during direct laryngoscopy by placing the patient into the proper head-elevated laryngoscopy position (HELP). In morbidly obese patients, achieving this position is important,12 and requires a great deal of support under the head and shoulders that could not be performed singlehandedly.13 The RAMP is an easy-to-use, quick device, taking an average of 56 seconds to place and inflate.14

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • The 50 subjects will be adult surgical candidates age 18-80, ASA I-III, BMI > 30 kg/m2 presenting for gastric bypass or laparoscopic gastric banding surgery who require general anesthesia.

排除标准

  • Patients will be excluded if it is determined that an awake intubation should be performed. Mallampati IV and ASA IV-V patients will also be excluded, as well as patients with unstable cervical, thoracic and/or lumbar fracture.

结局指标

主要结局

Ease of Mask Ventilation as Assessed by Han Class

时间窗: Time before intubation

Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant

Glottic View as Assessed by the Cormack and Lehane Classification

时间窗: before intubation

Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible

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

Carin A. Hagberg

Professor and Chair - Anesthesiology

The University of Texas Health Science Center, Houston

研究点 (2)

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