Safety and Efficacy of Laryngeal Mask Airways in Sinonasal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
研究概览
简要总结
Laryngeal mask airways (LMA) have been shown to be a safe mode of airway management when delivering general anesthesia to patients during a variety of operative procedures. LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike. This study will aim to demonstrate the safety and efficacy of LMA for airway management during sinonasal surgery by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
详细描述
LMA's have been studied in a wide range of otolaryngologic procedures, and are generally safe and accepted by both anesthesia providers and surgeons alike, as a safe mode of airway management when delivering general anesthesia. In sinonasal surgery, however, there are more concerns regarding the use of LMA's for airway management. Due to the nature of sinonasal procedures, the patient is exposed to blood and secretions that may drip/flow from the nasal cavity into the oropharynx and potentially into the upper and lower airways if not protected adequately. Additionally, often times, manipulation of the patient's head throughout the procedure is encountered to improve operative positioning. As a result, both surgeons and anesthesiologists have been hesitant to utilize LMA's in these types of surgeries despite documented benefits of increased patient comfort, fewer hemodynamic fluctuations during induction of anesthesia, and better controlled emergence when using LMA's.
Specific Aims The overall purpose of this study is to demonstrate the ability to provide safe and effective ventilation and airway protection with a laryngeal mask airway (LMA) during sinonasal surgery, by directly comparing them to endotracheal intubation in a prospective randomized single-blind study.
Aim 1: Analyze and compare the incidence and severity of airway contamination/aspiration of blood and secretions during sinonasal surgery and reveal any statistically significant difference between LMA and endotracheal intubation.
Aim 2: Analyze and compare the incidence of various outcome measures including laryngospasm, bronchospasm, anesthesia time, recovery time, post-op pain medication requirements, and airway complications between LMA and endotracheal intubation.
Aim 3: Analyze and compare both patient comfort and surgeon satisfaction after procedure between LMA and endotracheal intubation groups.
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
- Single (Participant)
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
- •Adult patients (18 yo or older) undergoing elective sinonasal procedures including rhinoplasty, septoplasty, and paranasal sinus surgery estimated blood loss will be less than 300cc and the length of the procedure will be expected to last 2 hours or less
- •American Society of Anesthesiologists (ASA) scores 1-3
- •Mallampati classification 1-3
排除标准
- •Currently pregnant
- •History of obstructive sleep apnea with history of difficulty with ventilation
- •Mouth opening less than 3cm
- •Indications for fiberoptic intubation present
- •Upper aerodigestive tract mass or malignancy
- •Procedure deemed emergent
- •Severe gastroesophageal reflux, severe cardiac, pulmonary, renal or hepatic co-morbidities
- •Unable to consent to study
研究组 & 干预措施
Endotracheal intubation
Endotracheal intubation for airway management and ventilation during sinonasal surgical procedure
干预措施: Mallinckrodt Endotracheal Tube (ETT) (Device)
Laryngeal mask airway
Laryngeal mask for airway management and ventilation during sinonasal surgical procedure
干预措施: Laryseal Laryngeal mask airway (LMA) (Device)
结局指标
主要结局
Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score
时间窗: intraoperative, within about 1 hour
Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).
次要结局
- Post-op Pain Med Requirements(48 hour medicine requirement)
- Anesthesia Time in Minutes(beginning and end of anesthesia (approximately 2 hours))
- Recovery Time in Minutes(time spent in recovery room after surgery (approximately 4 hours))
- Presence of Laryngeal Spasm(From start of anesthesia through hospital discharge (approximately 6 hours))
- Presence or Absence of Airway Complications(Start of surgery through hospital discharge (approximately 6 hours))
研究者
Justin Turner
Assistant Professor of Otolaryngology-Head and Neck Surgery, Assistant Professor of Biomedical Engineering
Vanderbilt University Medical Center