Cuff Pressure During Surgical Retractor Splay and Postoperative Voice Outcome After Anterior Cervical Spine Surgery: Comparison Between Tapered-shaped and Conventional Cylindrical-shaped Endotracheal Tube
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Just seal tracheal tube cuff pressure
研究概览
简要总结
This is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.
详细描述
High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome. The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP during retractors splay and improve voice recovery after ACSS. In this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be intubated by an anesthesiologist who is aware of the grouping. After tracheal intubation is finished, the cuff is connected to the pressure monitor system and another blinded assessor will adjust and record the minimal volume that is required for sealing the tracheal tube-ventilator. The cuff pressure will be monitored and recorded all throughout the surgical period. A blinded assessor will follow up the patient after the surgery and do the voice analysis. Patients are unaware of the type of tracheal tube they used and will score subjectively for the sore throat and postoperative dysphonia.
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving elective anterior cervical spine surgery
- •Right side approach
排除标准
- •Unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies)
- •Anticipated difficult airway
- •Facial anomaly that may hinder facemask ventilation
- •Preoperative hoarseness or vocal cord palsy regardless of etiology
- •Re-operation of cervical spine surgery or left side approach
- •Operation field involved cervical spine C1 or C2
- •Unwilling to sign the informed consent
- •Unwilling to finish the study
结局指标
主要结局
Just seal tracheal tube cuff pressure
时间窗: 1 minute after anesthesia and tracheal intubation
Minimal tracheal tube cuff pressure that prevent leakage of the ventilator system
Tracheal tube cuff pressure on retractor splay
时间窗: Intraoperative monitoring
Cuff pressure when the retractors are set-up and removed
次要结局
- Sore throat-NRS(preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7)
- Sore throat-VAS(preOP(operation) day 1, post OP 2 hours, day 1, 2, 3, 7)
- Subjective dysphonia(preOP day 1, post OP 2 hours, day 1, 2, 3, 7)
- Subjective dysphonia-GRBAS score(One day before operation, and post operation day 1)
- Subjective dysphonia- Voice Handicap Index-10(VHI-10)(One day before operation, and post operation day 7)
- Objective dysphonia(One day before operation(baseline), and post operation day 1)
- Postoperative complication(After operation to post operation day 7)
研究者
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Ya-Chun Chu, MD, PhD, Division of Neuroanesthesia, Department of Anesthesiology
Taipei Veterans General Hospital, Taiwan