Transcricoid Injection vs. Spray as You go Method for Local Anaesthesia During Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA): A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Overall cough count
研究概览
简要总结
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS -TBNA) is commonly performed for diagnosis of mediastinal pathologies. The procedure can either be performed under general anaesthesia or under moderate sedation with topical anaesthesia. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. Topical lignocaine is administered during endobronchial ultrasound for local anaesthesia. There is limited literature on the efficacy of transtracheal/transcricoid injection versus spray as you go method for lignocaine delivery to the airways during EBUS-TBNA. This study would help to determine the procedure comfort for the patient while using the transtracheal/transcricoid method vs the spray as you go method.
详细描述
For all patients meeting the inclusion criteria, the demographic profile including age, sex, weight, smoking history shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo EBUS-TBNA under moderate sedation would be randomised in a one is to one ratio either to transcricoid injection or spray as you go lignocaine group. Prior to EBUS-TBNA, Blood pressure, pulse rate, respiratory rate and pulse oximetry saturation will be recorded at the baseline Patients in both the groups shall be prepared in a similar fashion except for the use of transcricoid injection in one group.
During the procedure, 2 ml aliquots of 1% lignocaine solution will be delivered through the bronchoscope when using spray-as-you go technique. Patients in the transcricoid group shall initially receive 5 ml of 2% lignocaine solution and additional aliquots of 1% lignocaine using the spray as you go method. The total lignocaine dose during the procedure will be recorded. The patients would be monitored for any adverse effects throughout the procedure. The bronchoscopist doing the procedure will be provided VAS charts to mark the severity of cough and overall procedure satisfaction. An audio recorder shall be used to record the cough count during the entire procedure.
Post procedure, patients will record the pain experienced while undergoing the procedure on the VAS scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Indication for EBUS TBNA
- •Age > 18 years
排除标准
- •Refusal of consent
- •Known documented hypersensitivity to lignocaine
- •Procedure performed under general anaesthesia
- •Pregnancy
- •Hypoxemia (oxygen saturation [by pulse oximetry] < 92% with Fio2 of ≥ 0.3
- •Bronchoscopy done through endotracheal or tracheostomy tube
- •Midline neck mass or thyroid enlargement making the identification of
- •cricothyroid membrane difficult'
- •Patients with central airway obstruction
- •Patients with active ongoing hemoptysis
研究组 & 干预措施
Transcricoid
Lignocaine delivery using transcricoid injection
干预措施: Transcricoid Injection (Drug)
Spray as You go
Lignocaine delivery using spray as you go method
干预措施: Spray as you go (Drug)
结局指标
主要结局
Overall cough count
时间窗: At study completion approximately 12 months
Cough count till reaching carina
Operator rated overall procedure satisfaction
时间窗: Through study completion, an average of 1 year
Operator rated satisfaction on VAS scale
次要结局
- Overall procedure duration(At study completion approximately 12 months)
- Time from scope insertion to crossing the vocal cords(At study completion approximately 12 months)
- Total Lignocaine dose(At study completion approximately 12 months)
研究者
Karan Madan
Dr. Karan Madan, MD, DM Assistant Professor, Pulmonary Medicine and Sleep Disorders
All India Institute of Medical Sciences, New Delhi