Airway Management, Laparoscopy, Supraglottic Airway Devices
Conditions
Brief summary
The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position. Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.
Detailed description
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
Interventions
DEVICEAmbu AuraGain evaluation
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
DEVICELMA Supreme evaluation
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
PROCEDURELaparoscopic surgery
Gynecologic laparoscopic surgery in the trendelemburg position
Sponsors
Ambu A/S
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Airway seal pressure | At 15 minutes | Maximum airway pressure that the device can achieve without oropharyngeal leak of gas. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of ventilation | At baseline and at 15, 30 and 60 minutes | number of manoeuvres/corrections required |
| Ease of insertion of the device | Baseline | Time needed to insert the device |
| Endoscopic view of glottic structures | At 15 minutes | Assessment of alignment with the glottic inlet as: complete view of the vocal cords (I), epiglottis visible inside, but not causing any obstruction (II), epiglottis visible and causing obstruction (III) or glottis not identified (IV) |
| Gastric tube insertion | At 5 minutes | Ease of passage of a gastric tube as: easy, difficult or impossible |
| Incidence of perioperative complications | 2 hours | number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat |
Countries
Spain
Outcome results
None listed