The Effect of The Use of a Videolaryngoscope and/or Stylet on Intubation Time in Obese Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Intubation Time Using a Stop Watch
研究概览
简要总结
Although many researchers would agree that obesity per se is not a risk factor for difficult intubation, there are many well known obesity-related challenges in airway management including difficulty with mask ventilation, more frequent and rapid oxygen desaturation, increased oxygen consumption, and increased sensitivity to the respiratory depressant effects of anesthetic and analgesic drugs. Hence, in these conditions, rapid and nontraumatic intubation gain higher interest. There is controversy about using videoaryngoscopy (VL) in obese patients in these difficult situations. The primary aim of this study is to compare, in terms of intubation time, VL,VL plus stylet and direct-laryngoscopy(DL) plus stylet combination with DL alone in obese patients.
详细描述
Patients who will be scheduled for surgeries requiring endotracheal intubation, with a body mass index (BMI) more than 30 kg/m2, will be included to this study. During preanesthetic visit (performed by an anesthesiologist not involved in this study) history of difficult intubation, measurement of common predictive indices for difficult intubation (BMI, thyromental distance, neck circumference, Mallampati grade, interincisal [or intergingival] distances), and evaluation of status of dentition and neck movement will be noted.
In the operating room, all patients will be connected to standard monitoring devices. Anesthesia induction will be carried out according to our hospital obese patient anesthesia management protocol. Then, after induction of anesthesia, the patients will be intubated one of four pre-defined protocols that will be determined via randomization during a preanesthetic visit by a person who is unfamiliar with the research protocol.
Primary hypothesis of this study is; using a video-laryngoscope plus stylet will reduce the time required to achieve successful tracheal intubation in obese patients.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participant and the healthcare worker who will perform preoperative and postoperative visit will be blinded to randomized study group.
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
- 是
入选标准
- •Patients with a documented body mass index (BMI) of ≥
- •Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
- •Willingness and ability to sign an informed consent document 18 - 80 years of age
排除标准
- •Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
- •Patients with a history of facial abnormalities, oral-pharyngeal cancer, or reconstructive surgery
- •Emergency surgeries
- •Pregnancy
- •Any other conditions or use of any medication which may interfere with the conduct of the study.
结局指标
主要结局
Intubation Time Using a Stop Watch
时间窗: Up to 3 minutes
The timing measurements will begin once the laryngoscope blade will be placed in the patient's mouth and ended when an end-tidal CO2 tracing will be detected.
次要结局
- Glottis View Using the Cormack Lehane Score(Up to 1 minute)
- Number of intubation attempts(Up to postinduction 120 second)
- Saturation(Before induction to 3 min after intubation)
- Complications related to intubation(postoperative 4th hour)
- Incidence of severe complications following intubation(During intubation to 3 min after intubation)
- Heart Rate(Before induction to 3 min after intubation)
- Mean Arterial Pressure:(Before induction to 3 min after intubation)
- Glottis View Using the POGO Score(Up to 1 minute)
- Ease of Intubation(Up to 1 minute)