Comparison of Left Paratracheal Versus Cricoid Pressure on Glottic Visualization During Videolaryngoscopy: A Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Glottic Opening (POGO) score
研究概览
简要总结
This randomized crossover study evaluates the effects of left paratracheal pressure, cricoid pressure, and no pressure on glottic visualization during videolaryngoscopy in adult surgical patients. The primary endpoint is the Percentage of Glottic Opening (POGO) score assessed by blinded video review. Secondary endpoints include anatomical measures (glottic surface area, vertical and horizontal displacement of the glottic plane) and clinical outcomes (first-pass success, first-pass success without desaturation <90%, intubation time, Intubation Difficulty Scale, hypoxemia, hemodynamic events, airway trauma, and postoperative sore throat or dysphonia). All outcomes are collected from routine anesthetic practice and video analysis, with no additional procedures.
详细描述
This randomized crossover trial will compare three laryngoscopy conditions (no pressure, cricoid pressure, left paratracheal pressure) in adult surgical patients requiring general anesthesia with tracheal intubation. Each patient undergoes all three conditions in random order, with the intubation performed using the maneuver chosen by the operator. Anatomical outcomes (POGO, glottic surface area, vertical and horizontal displacement of the glottic plane) will be assessed from video recordings by blinded evaluators. Clinical outcomes (first-pass success, composite success without desaturation <90%, intubation time, IDS, hypoxemia, hemodynamic changes, airway trauma, sore throat, dysphonia) will be collected from routine anesthetic records and PACU assessments.
Statistical Analysis Plan:
POGO: mixed-effects repeated measures model with patient as random effect, maneuver as fixed effect, adjusted for operator, BMI, and Mallampati.
Anatomical outcomes: analyzed similarly with mixed models and planned contrasts (LPP vs CP).
Clinical outcomes: analyzed as-treated, using logistic or linear regression with adjustments for baseline factors and operator as random effect.
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
- Single (Outcomes Assessor)
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 years
- •Scheduled for elective surgery under general anesthesia requiring endotracheal intubation
- •ASA physical status I or II
- •Normal airway anatomy as assessed by the anesthesiologist (Mallampati I-II, no known or anticipated difficult airway)
- •Written informed consent obtained prior to inclusion
排除标准
- •History of difficult intubation or anticipated difficult airway
- •Known upper airway anatomical abnormalities (e.g., tumors, tracheal deviation, cervical spine instability)
- •BMI > 35 kg/m²
- •Gastroesophageal reflux disease or increased aspiration risk
- •Pregnancy
- •Emergency surgery
- •Allergy or contraindication to any anesthetic drugs used
- •Inability to provide informed consent
研究组 & 干预措施
No Pressure (Baseline)
Videolaryngoscopy performed without any external laryngeal pressure. This serves as the baseline condition for each patient.
Cricoid Pressure (30 N)
Videolaryngoscopy performed while applying standardized cricoid pressure (30 N) by a trained operator. A video image is captured during this maneuver.
干预措施: Cricoid Pressure (30 N) (Procedure)
Left Paratracheal Pressure (30 N)
Videolaryngoscopy performed while applying standardized left paratracheal pressure (30 N) by the same operator. A video image is captured during this maneuver.
干预措施: Left Paratracheal Pressure (30 N) (Procedure)
结局指标
主要结局
Percentage of Glottic Opening (POGO) score
时间窗: During laryngoscopy, before tracheal intubation
POGO will be scored from video recordings of each condition (no pressure, cricoid, paratracheal) by blinded assessors (0-100%).
次要结局
- First-attempt success without desaturation < 90%(From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes.)
- Glottic surface area(During laryngoscopy, before intubation)
- Vertical Displacement of the Glottic Plane(During laryngoscopy, before intubation)
- Horizontal displacement of the glottic plane(During laryngoscopy, before intubation)
- First-pass intubation success(From laryngoscope insertion to first confirmed capnography)
- Time to intubation(From laryngoscope insertion to first confirmed capnography)
- Intubation Difficulty Scale (IDS)(During intubation)
- First-attempt success without desaturation < 90%(From laryngoscope blade past the incisors until confirmed tracheal intubation (end-tidal CO₂ ≥ 5 mmHg for 3 breaths), typically up to 2 minutes.)
- Hypoxemia(From induction until confirmed intubation)
- Hemodynamic events(From induction until confirmed intubation)
- Airway trauma(Immediately after intubation)
- Postoperative sore throat(30-60 minutes in PACU)
研究者
Benjamin Javillier, MD
Principal Investigator
University of Liege