Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery
关键词
抽象
描述
The patients are randomly assigned to 2 groups:
- Group 1: Ambu AuraGain.
- Group 2: LMA Supreme, Teleflex
Procedure:
The investigation protocol contains the following sections:
1. Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
2. Insertion of the SGAs. The size of the SGA device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
3. Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
4. Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
6. Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes.
Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 < 92%)
7. Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale
日期
| 最后验证: | 01/31/2016 |
| 首次提交: | 07/19/2015 |
| 提交的预估入学人数: | 07/27/2015 |
| 首次发布: | 07/29/2015 |
| 上次提交的更新: | 02/18/2016 |
| 最近更新发布: | 02/21/2016 |
| 实际学习开始日期: | 05/31/2015 |
| 预计主要完成日期: | 11/30/2015 |
| 预计完成日期: | 11/30/2015 |
状况或疾病
干预/治疗
Device: Ambu AuraGain
Device: LMA Supreme
Procedure: Laparoscopic surgery
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Ambu AuraGain Insertion of the supraglottic device and evaluation of its clinical performance | Device: Ambu AuraGain Evaluation of clinical performance in terms of Insertion, ventilation, position and complications |
| Active Comparator: LMA Supreme Insertion of the supraglottic device and evaluation of its clinical performance | Device: LMA Supreme Evaluation of clinical performance in terms of Insertion, ventilation, position and complications |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients evaluated as eligible for a SGA - ASA I-III - Without criteria for difficult airway - Body Mass Index ≤ 35 kg/m2 - The patient has signed the Informed Consent - The patient understands his or hers rights and consequences related to this investigation Exclusion Criteria: - Planned operation time > 2 hours - High risk of regurgitation - Respiratory tract pathology - Preoperative sore throat - Patients with a known or predicted difficult airway - Patients diagnosed with dementia or any mental handicaps - Patient who has a guardian. |
结果
主要结果指标
1. Airway seal pressure [At 15 minutes]
次要成果指标
1. Ease of insertion of the device [Baseline]
2. Change in Quality of ventilation [At baseline and at 15, 30 and 60 minutes]
3. Endoscopic view of glottic structures [At 15 minutes]
4. Gastric tube insertion [At 5 minutes]
5. Incidence of perioperative complications [2 hours]
