Transcricoid Injection Versus Spray as You go Method for Local Anaesthesia During Flexible Bronchoscopy: 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
- 500
- 试验地点
- 1
- 主要终点
- Cough count from bronchoscope introduction till reaching the carina
研究概览
简要总结
Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Use of sedation during bronchoscopy has been reported to improve procedure tolerance. However, awake(no sedation) bronchoscopy is routinely performed at many centres including ours.
Topical lignocaine is administered during bronchoscopy 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 bronchoscopy. 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 and the type of procedures performed during bronchoscopy shall be recorded. A written informed consent will be obtained from all participants. The patients who undergo flexible bronchoscopy would be randomised in a one is to one ratio either to transcricoid or spray as you go group. Prior to the bronchoscopy 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 initial route of lignocaine delivery.
During the procedure, 1.5 ml aliquots of 2% 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 instilled transtracheally along with two baseline 1.5 cc bronchial spray aliquots of lignocaine, and additional aliquots of 2% 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 2 VAS charts to mark the severity of cough and overall procedure satisfaction. Cough count shall be noted.
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 diagnostic or therapeutic flexible bronchoscopy
- •Age > 18 years
- •Hemodynamic stability (defined as systolic BP >100 mm Hg and, <180 mm Hg).
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
Cough count from bronchoscope introduction till reaching the carina
时间窗: At study completion approximately 12 months
次要结局
- Time from scope insertion to crossing the vocal cords(At study completion approximately 12 months)
- Total Lignocaine dose(At study completion approximately 12 months)
- Overall procedure duration(At study completion approximately 12 months)
- Operator rated overall procedure satisfaction(Through study completion, an average of 1 year)
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