Evaluation of the Use of Tracheal Intubation Through a Laryngeal Tube to Intubate Anesthetized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- To evaluate success of fiberoptic guide endotraqueal intubation through an I-LTSD device in patients to general anesthesia without difficult intubation.
研究概览
简要总结
Failed intubation is currently one of the most important factors leading to morbidity and mortality in anesthesia.
The development of supraglottic airway devices (SGDs), such as the intubating laryngeal tube, has revolutionized airway management, as these devices allow adequate ventilation and oxygenation in situations where ventilation and/or intubation via conventional means pose a challenge. Several publications describe the usefulness of such devices for salvaging ventilation in patients that cannot be intubated with direct laryngoscopy or who cannot be ventilated with a facemask. In these salvage situations, SGDs are highly effective in achieving adequate patient oxygenation.
Achieving effective oxygenation with an SGD and completely isolating the airway by intubation at the same time. This is now possible thanks to the so called supraglottic intubation devices (SGIDs). For that reason, we believe it is necessary to conduct a study that allows evaluation of the performance of this device in the context of daily clinical practice.
Its design characteristics, its capacity to be used in intubation applications, its soft and atraumatic materials as well as its disposability augur this product a significant expansion in the next few years. Nonetheless, no data are available on the success of intubation when the intubating laryngeal tube suction device (ILTSD) is used. The idea behind this study is to assess the possibilities to use the ITLSD device to intubate patients in regular anesthetic practice.
详细描述
The development of supraglottic airway devices (SGDs), such as the intubating laryngeal tube, has revolutionized airway management, as these devices allow adequate ventilation and oxygenation in situations where ventilation and/or intubation via conventional means pose a challenge. It would seem ideal to be able to unify both techniques in one single device; in other words, achieving effective oxygenation with an SGD and completely isolating the airway by intubation at the same time. This is now possible thanks to the so-called supraglottic intubation devices (SGIDs). For that reason, we believe it is necessary to conduct a study that allows evaluation of the performance of this device in the context of daily clinical practice.
LOCATION: The study will be conducted at operating rooms serving inpatients at the Valencia Clinical University Hospital. Investigators will be anesthesiologists with long experience in fibroscopy and in the management of supraglottic devices used for intubation.
METHODOLOGY: Prospective observational study aimed at evaluating the success of intubation through an I-LTSD device in regular clinical practice.
Research population: The study population will be made up of adult patients undergoing elective surgery who require general anesthesia and endotracheal intubation. Patients will be included in a consecutive manner provided that selection criteria are met. All patients will be required to sign an informed consent form.
Study variables: Information on the following variables will be gathered:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •ASA I, II & III.
- •Outpatient and inpatient surgery requiring endotracheal intubation. Signature of an informed consent form.
排除标准
- •Patients who, on initial airway examination, exhibit any of the following conditions associated with a difficult airway: cervical spine pathology, mouth opening restriction of less than 3 cm. (combination of Mallampati class III-IV, thyromental distance < 6 cm and reduced mouth opening).
- •A history of severe gastroesophagic reflux and/or a history of recent respiratory infection.
- •Refusal of the patient to participate in the study.
结局指标
主要结局
To evaluate success of fiberoptic guide endotraqueal intubation through an I-LTSD device in patients to general anesthesia without difficult intubation.
时间窗: one day
The study will determinate the success of visual fiberoptic intubation at a first and a second attempt and guided fiberoptic intubation at a third and last attempt. Should the third attempt fail, intubation will be performed through direct or indirect laryngoscopy. The initial success rate will be calculated and the number of attempts needed for successful intubation will be recorded.
次要结局
未报告次要终点
研究者
pedro charco mora
Director
Formacion Internacional para la Docencia e Investigación de la Vía Aérea