A Comparison of Tracheal Intubation Using the Totaltrack vs the Macintosh Laryngoscope
试验速览
- 阶段
- 不适用
- 发起方
- AnestesiaR
- 入组人数
- 1,440
- 试验地点
- 2
- 主要终点
- saturation of blood oxygen at the end of orotracheal intubation
研究概览
简要总结
Airway management in obese patients has to consider that mask ventilation (DMV) risk is increased and difficult tracheal intubation (DTI) risk may be increased too.
In obese patients, is essential to prevent early arterial oxygen desaturation related to a reduced functional residual capacity (FRC), atelectasis formation during anesthetic induction and after tracheal intubation, because oxygenation maintenance is the cornerstone of the airway management of the obese patient.
Endotracheal intubation is usually required to allow unrestricted surgical approach. The Macintosh laryngoscope is the standard method. However, sometimes this technique is ineffective and poorly tolerated by the obese patient.
The Totaltrack™ (MedComflow S.A., Barcelona, Spain) is a hybrid device, between a supraglottic airway and a videolaryngoscope with an anatomically shaped blade. It allows fibreoptic visualization of the larynx for tracheal intubation and was developed to aid both ventilation and tracheal intubation, at the time of anticipated and unanticipated difficult airway management.
However, despite its use in clinical practice, there are no comparative studies regarding direct laryngoscopy in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Scheduled surgeries that require orotracheal intubation.
- •General anesthesia with neuromuscular relaxation before intubation.
- •Patients who sign informed consent.
排除标准
- •Difficult airway already known.
- •Alterations of airway documented, with previous tracheostomy or involve anatomical alterations.
- •General anesthesia that not require orotracheal intubation or neuromuscular relaxation.
- •Symptomatic gastro-esophageal reflux.
- •Lap-Band carrier.
- •Allergy medications to use.
- •Urgent surgery.
结局指标
主要结局
saturation of blood oxygen at the end of orotracheal intubation
时间窗: Time of Orotracheal intubation (TOTI) (up to 1 hour)
We will compare the blood oxygen saturation at the end of orotracheal intubation with macintosh and totaltrack. The end of successful tracheal intubation will be established to obtain a curve of Capnography.
次要结局
- Total time of successful intubation(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- number of maneuvers(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- IDS Scale(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- POGO Score(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- Number of attempts of endotracheal intubation(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- hemodynamic response(TOTI pre and postintubation (up to 10 minutes))
- Degree of satisfaction of the researcher(time of postintubation (up to 10 minutes))
- adverse effects encountered during intubation(Time of Orotracheal intubation (TOTI) (up to 1 hour))
- Complications(Time Frame: TOTI and postintubation (up to 24 hours))
研究者
Eugenio Martinez Hurtado
Principal Investigator
AnestesiaR