Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

Hospital Clinic of Barcelona

Status: Completed

Conditions: Laparoscopy; Supraglottic Airway Devices; Airway Management

Treatments: Procedure: Laparoscopic surgery; Device: LMA Supreme evaluation; Device: Ambu AuraGain evaluation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02511652

HBarcelona

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ambu AuraGain

Active Comparator group

Description:

Insertion of the supraglottic device and evaluation of its clinical performance

Treatment:

Procedure: Laparoscopic surgery

Device: Ambu AuraGain evaluation

LMA Supreme

Active Comparator group

Description:

Insertion of the supraglottic device and evaluation of its clinical performance

Treatment:

Device: LMA Supreme evaluation

Procedure: Laparoscopic surgery