Thyroid Cartilage Plane Versus Superior Laryngeal Nerve Space for Ultrasound-guided Superior Laryngeal Nerve Block in Awake Tracheal Intubation: a Randomised Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- The proportion of patients with acceptable intubation conditions (AIC)
研究概览
简要总结
The aim of this clinical trial is to compare the effectiveness and safety of ultrasound-guided thyroid cartilage plane approach with the superior laryngeal nerve space approach for superior laryngeal nerve block in awake tracheal intubation. Patients were randomized into the thyroid cartilage plane block group (T group) or the superior laryngeal nerve space block group (C group). In Group T, bilateral thyroid cartilage plane block was performed under ultrasound with thyroid cartilage as the landmark, and local anesthetic was injected on the surface of the thyroid cartilage. In Group C, local anesthetic was injected into the space between the thyrohyoid membrane and muscle groups above.
The investigators aim to evaluate whether the thyroid cartilage plane approach is not inferior to the superior laryngeal nerve space approach for ultrasound-guided superior laryngeal nerve block in awake tracheal intubation
详细描述
After entering the operation room, ECG, SPO2, and invasive blood pressure were monitored. Sedation was facilitated. The proper anaesthesia depth was maintained at 60-80 using the bispectral index. Additionally, 0.5 mg of Penehyclidine Hydrochloride was injected intravenously once the venous access was established. 100% oxygen 4 L min-1 was administered with a nasal cannula throughout the procedure. All patients received topical pharyngeal anesthesia using lidocaine spray. The investigators used a 5-12 MHz linear probeto perform bilateral block. The probe was placed parasagittally to locate the thyroid cartilage and superior laryngeal nerve space. After identification of related structure, the investigators advanced a 22-gauge needle medial to the transducer at the upper half of the thyroid cartilage laminae until it touched the laminae or superior laryngeal nerve space using the out-of-plane technique. The correct location of the needle tip in the fascial deep to the muscle groups was confirmed by injecting 0.5-1 ml saline. A total of 2% lidocaine 2.5 ml was administered after negative aspiration bilaterally. "Spray-as-you-go" technique guided by a fiberoptic bronchoscope was performed to the tracheal with 5 ml of 2% lidocaine. After airway anesthesia, intubation completed.
The primary outcome was the proportion of acceptable intubation conditions (AIC). Secondary outcomes were the performance time, Ramsay sedation score, the patient's cough condition, comfort score, and tracheal tube tolerance score and other perioperative complications including airway hemorrhage and superior laryngeal nerve damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for awake tracheal intubation under general anesthesia.
- •Patients with difficult airways (e.g., limited cervical spine mobility, full stomach, partial airway obstruction, craniofacial deformities or trauma, micrognathia, mouth opening <3cm, Mallampati III or IV classification) posing challenges for mask ventilation or intubation.
- •Age between 18 and 85 years old.
- •Gender is not restricted.
- •ASA classification of I - III.
排除标准
- •Cardiovascular dysfunction or arterial aneurysms.
- •Mental or neurological disorders or concomitant arterial aneurysms.
- •Infection at the puncture site.
- •Allergy to local anesthetics.
- •Continuous use of antiplatelet or anticoagulant medications preoperatively.
- •Hoarseness or coughing while drinking water.
- •Bronchial asthma.
- •Participation in other clinical trials within the previous 3 months before enrollment 9.r current participation in other clinical trials.
研究组 & 干预措施
Thyroid Cartilage Plane Block Group (T Group)
All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Ultrasound-guided bilateral Thyroid Cartilage Plane Block is performed using the thyroid cartilage as an anatomical landmark. 2.5ml of 2% lidocaine is injected on the surface of the thyroid cartilage each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 2% lidocaine 5ml. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation.
干预措施: Ultrasound-guided bilateral Thyroid Cartilage Plane Block (Procedure)
Superior Laryngeal Nerve Space Block Group (C Group)
All patients received topical oral and pharyngeal anesthesia using 2.4% lidocaine spray. The pharyngeal surface was sprayed twice, with each spray lasting one second, and repeated after a 5-minute interval. Under ultrasound guidance, the needle was advanced step by step into the potential space between the relevant muscle groups and the thyrohyoid membrane. When the needle tip contacted the surface of the thyrohyoid membrane and slightly penetrated the submembranous tissue, negative aspiration was confirmed, and 2.5 mL of 2% lidocaine was injected into the space on each side. Subsequently, performing fiberoptic bronchoscope-guided subglottis and tracheal surface topical anesthesia using 5ml of 2% lidocaine. After completing surface anesthesia, performing fiberoptic bronchoscope-guided tracheal intubation.
干预措施: Ultrasound-guided bilateral Superior Laryngeal Nerve Space Block (Procedure)
结局指标
主要结局
The proportion of patients with acceptable intubation conditions (AIC)
时间窗: Upon intubation
The evaluation of the intubation condition was based on the Cormack-Lehane classification, vocal cord movement, 5-point reaction scale, and severity of coughing. Clinically, AIC was defined when each part was scaled to Grade 1 or Grade 2. The proportion of AIC = number of participants with AIC/number of participants who received ATI in each group.
次要结局
- The tolerance score after the tube insertion(Five minutes after successful intubation)
- Quality of airway anesthesia(Upon intubation)
- Mean Arterial Pressure(T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation)
- Heart Rate(T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation)
- Ramsay Sedation Score(T0: upon entry to the operating room,T1: before insertion of the tracheal tube,T2: immediately after tracheal tube insertion,T3: 5 minutes after successful intubation)
- The number of patients with lowered pitch(Before intubation)
- The time needed for blockade procedure(From ultrasounography localization to completion of local anesthetic administration)
- Record coughing in patients when the fiberoptic bronchoscope touches the glottis(Before intubation)
- Adverse reactions such as coughing and nausea/vomiting(During intubation)
- Occurrences of sore throat and lowered pitch(Post-extubation,24 hours after surgery)
- Total procedure time needed for awake intubation(From the initiation of topical anesthesia to the accomplishment of tracheal intubation)
- Airway hemorrhage or nerve damage(During intubation)
研究者
Tao Shan
Attending physician
Nanjing First Hospital, Nanjing Medical University