The Articulated Oral Airway as an Aid to Mask Ventilation, a Prospective Interventional, Non-Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Expiratory Tidal Volume (Breaths 6-10)
研究概览
简要总结
The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The investigators hypothesize that, in patients with predictors for difficult mask ventilation, the AOA will be non-inferior to the Geudel oral airway in terms of expired tidal volumes.
详细描述
Difficult mask ventilation (MV) is common in the obese population and can result in patient morbidity and mortality. The Articulating Oral Airway (AOA) is a novel oral airway which actively displaces the tongue, allowing for a greater cross-sectional area for MV. The investigators hypothesize that, while using the same ventilatory pressure in neuromuscularly blocked patients with predictors for difficult mask ventilation, MV with an AOA will not result in smaller expired tidal volumes than MV with a similarly sized Guedel oral airway (GDA). In other words, the AOA will be non-inferior to the GDA in terms of expired tidal volumes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Anesthesia facemasks will be opacified so that the clinical provider will be blinded to which oral airway (Guedel vs AOA) is being used and in what order. The patient will be anesthetized and thus blinded. The Investigator and Outcomes Assessor will only see video of the data on the anesthesia monitor (not the patient/device/etc) and will thus be blinded. The only individuals who will not be blinded are the Research Assistants who will not be involved in data analysis.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals demonstrating 2 or greater predictors of difficult mask ventilation (as listed below) who are scheduled for elective surgery with general anesthesia and asleep mask ventilation/orotracheal intubation utilizing long-acting neuromuscular blockade.
- •Predictors of difficult mask ventilation i) Age > 55 years ii) BMI > 30kg/m2 iii) Beard iv) Lack of teeth v) History of snoring
排除标准
- •Documented history of impossible mask ventilation
- •Planned omission of mask ventilation ('rapid-sequence induction,' etc.)
- •Planned omission of long-acting paralytics
- •Need for awake airway management
- •Need for emergent airway protection
- •Presence of oropharyngeal anatomic abnormalities
- •Distance from the maxillary incisors to the angle of the mandible <11cm
- •<18 years of age
- •Known pregnant state
- •Current incarceration
- •Refusal to be involved in the study
研究组 & 干预措施
Guedel oral airway
Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Guedel oral airway first and measurements were taken during breaths 6 through 10. After its removal the Articulated Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.
干预措施: Guedel oral airway (active comparator) (Device)
Articulated Oral Airway
Each participant in the study will have both devices (GOA or AOA). The participants reported in this arm were randomized to receive the Articulated oral airway first and measurements were taken during breaths 6 through 10. After its removal the Guedel Oral Airway was inserted and measurements were repeated again during breaths 6 through 10.
干预措施: Articulated Oral Airway (Device)
结局指标
主要结局
Expiratory Tidal Volume (Breaths 6-10)
时间窗: Measured immediately after placement of each oral airway; an average of 2-5 minutes.
Measured expiratory tidal volume (from video of anesthesia monitor). Each participant had measurements collected during breaths number 6-10 after the insertion of each oral airway (GOA or AOA) with the order of first treatment randomized. The average expiratory tidal volumes reported were weight standardized per kilogram of participant's body weight, meaning the expiratory measurements were divided by the participant's weight (kg). A total of 56 patients were enrolled and randomized--28 received the Guedel Oral Airway first and 28 received the Articulated Oral Airway first. The average expiratory values are reported as outlined in table below: Guedel inserted first AOA inserted first Guedel inserted second AOA inserted second
次要结局
- Inspiratory Tidal Volume (Breaths 6-10)(Measured immediately after placement of each oral airway; an average of 2-5 minutes.)
- Immediate Oropharyngeal Trauma From Oral Airway Randomized to be Placed First(Measured immediately after removal of first oral airway and before placing the second oral airway)
研究者
Ron Abrons
Assistant Professor of Anesthesiology
University of Iowa