Pilot Study Comparing Intubation Via Video Laryngeal Mask Airways (VLMAs) Versus Video Laryngoscopy: Efficacy and Patient Outcomes in General Anesthesia Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy
研究概览
简要总结
The goal of this clinical trial is to compare the overall performance and patient outcomes of two video-assisted laryngeal mask airways (VLMAs) devices called Safe and Comfortable (SaCo) VLM and SafeLM® (Safe VLM) versus video laryngoscopy for airway management in adult patients, without an anticipated difficult airway, that are undergoing elective general anesthesia procedures.
The main question it aims to answer is: Can both VLMAs improve patient-centered outcomes in the perioperative and postoperative periods in comparison to endotracheal tube (ETT) intubation? Thirty participants will undergo randomized VLMA with either the Safe VLM (15 participants) or the SaCo VLM (15 participants). And 15 participants will be intubated with ETT using video laryngoscopy, as the control group. Researchers will evaluate the efficacy of these two video-assisted devices in adult patients without an anticipated difficult airway in elective general anesthesia procedures. Other patient outcomes and exploratory endpoints will be recorded as well.
详细描述
INVESTIGATIONAL DEVICES NAMES SaCo® (UESCOPE® 2) by UE Medical Devices, Inc SafeLM® Video Laryngeal Mask System by Magill Medical Technology Co. Ltd
STUDY RATIONALE New airway devices for anesthesiology are constantly being developed to improve patient overall safety, reduce perioperative risks and complications, enhance recovery, and prevent postoperative adverse-related outcomes. The first and second generation supraglottic airway devices (SADs) have satisfactory features which provide an effective airway and ventilation without the need for more aggressive endotracheal intubation. Nevertheless, these are inserted in a "blind" fashion; malpositioning and potential airway compromise occurs in 50-80% of placements.
Thus, direct vision-guided placement using newer third generation video laryngeal mask airways (VLMAs), can ensure optimal positioning, adequate lung ventilation, and perioperative real-time visualization of the airway. This allows for assessment and any needed corrective maneuvers if they become necessary. The two types of FDA-approved VLMAs that this study will test are: 1) the SafeLM® Video Laryngeal Mask System, which has a camera angle-adjusting handle that allows direct vision up to 140° angle of view of the oropharynx and larynx, with a monitor that is embedded in the device; and 2) the SaCo® Video Laryngeal Mask, which has an embedded camera fixed into the shaft of the device, which attaches to an external monitor. Both devices can guide endotracheal intubation through the ventilation channel under direct vision.
Recent studies have demonstrated the various applications of SaCo VLM for the management of difficult airways in adult patients requiring general anesthesia. This pilot study will be a single-center randomized controlled trial of 45 healthy adult patients undergoing general anesthesia. We aim to explore the efficacy of both VLMAs and evaluate patient perioperative and postoperative outcomes; both are expected to replicate and, possibly, even improve on the outcomes from the conventional video laryngoscopy.
INVESTIGATIONAL DEVICE INTENDED USE The intended use of the video-guided LMAs is to aid in optimal placement of supraglottic airway devices, which will require additional ETT intubation, in participants without anticipated difficult airways.
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)
盲法说明
Participant will have agreed to the study and randomized device or technique will be used.
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
- •Age ≥ 18 yrs
- •BMI ≥ 40 kg/m2
- •American Society of Anesthesiologists (ASA) class I-III
- •With intention to undergo endotracheal intubation
- •Understanding the purpose of the study and signing the informed consent
排除标准
- •History of upper respiratory infection within 2 weeks
- •Presence of risk factors for gastric reflux or aspiration
- •Symptomatic bronchial asthma
- •Restricted mouth opening (﹤2 cm)
- •Upper airway tumors, abscesses, foreign bodies or airway stenosis
- •Requiring one-lung ventilation for thoracic surgery
结局指标
主要结局
Successful first-attempt placement rate of endotracheal intubation via video laryngoscopy
时间窗: Intraoperative period, from the beginning of the general anesthesia induction to ETT placement, up to 45 seconds
Insertion will be considered successful if the endotracheal tube slides through the VLMA without any resistance and is confirmed to be optimally positioned based on observation via the laryngeal mask visual monitor screen and capnography. This will be reported as a dichotomous variable (successful vs unsuccessful).
Number of participants with change in heart rate by 20% from baseline heart rate
时间窗: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Measurement of heart rate will be taken before and after intubation.
Successful first-attempt placement rate of VLMA
时间窗: Intraoperative period, from the beginning of the general anesthesia induction to VLMA placement, up to 30 seconds
The first-attempt success rate of VLMA device placement will be determined. Insertion will be considered successful if the VLMA is placed without any resistance and is confirmed to be optimally positioned based on the laryngeal mask visual screen, end-tidal carbon dioxide (CO2) after placement and ventilatory parameters. This will be reported as a dichotomous variable (successful vs unsuccessful).
Number of participants change in oxygen saturation by 20% from baseline
时间窗: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Measurement of oxygen saturation will be taken before and after intubation.
Number of participants with change in mean blood pressure by 20% from baseline mean blood pressure
时间窗: Perioperative period, from the beginning of the general anesthesia induction to the end of evaluation, up to 1 day
Measurement of blood pressure will be taken before and after intubation.
Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events
时间窗: Postoperative period at 1 hour and 24 hours after procedure
Incidence of pharyngalgia, bleeding, hoarseness, and dysphagia events will be summarized as observed as reported by patients
次要结局
- Incidence of postoperative nausea and vomiting (PONV)(Postoperative period, up to one day following procedure)
- Number of participants with postoperative hypertension by >30% of baseline, requiring treatment(Postoperative period, up to 1 hour)