A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope in Difficult Airway: a Randomised, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Total time of successful intubation
研究概览
简要总结
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However in certain situations as difficult airway this technique is ineffective and poorly tolerated by the patient. Fiberoptic intubation is the gold standard in this scenario, however sometimes it is not possible due to failure or unavailability, so alternatives are needed. The TotalTrack (MedComflow SA, Barcelona, Spain) has been designed specifically for the airway management. However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective general anesthesia requiring OTI.
- •Patients duly informed and they have signed the informed consent during the pre-anesthetic consultation, or be sought after due meditation, expressing its consent to the inclusion in the study.
- •Age ≥18 years.
- •ASA I-III.
- •Sufficient intellectual capacity to understand the procedure and equipment used.
- •Predictors of difficult airway (Mallampatti class III or IV; thyromental distance <6 cm, sternomental distance <12.5 cm, interincisal distance<4.0 cm, bite test II or III, cervical mobility <90 ° or history of difficult intubation).
- •Thyroid surgery or present pharyngolaryngeal, glottic or cervical pathology
- •BMI >30kg / m2
- •Not presenting risk factors for aspiration
- •Not presenting respiratory disease, coronary or cerebral vascular.
- •Do not have a preoperative sore throat
排除标准
- •Failure to meet the above criteria
- •Pregnancy
- •Allergy to any drug included in the protocol.
结局指标
主要结局
Total time of successful intubation
时间窗: Time of Orotracheal intubation (TOTI) (up to 1 hour)
次要结局
- Complications(TOTI and postintubation (up to 24 hours))
- POGO Score(TOTI (up to 1 hour))
- endotracheal intubation success rate of each device(TOTI (up to 1 hour))
- Degree of satisfaction(time of postintubation (up to 10 minutes))
- IDS Scale(TOTI (up to 1 hour))
- number of maneuvers(TOTI (up to 1 hour))
- Number of attempts of endotracheal intubation(TOTI (up to 1 hour))
- Position taken by the anesthesiologist during orotracheal intubation(TOTI (up to 1 hour))
- hemodynamic response(TOTI pre and postintubation (up to 10 minutes))
研究者
Manuel Ángel Gómez-Ríos
M.D.
Complexo Hospitalario Universitario de A Coruña