Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Airway Management; Laparoscopy; Supraglottic Airway Devices
• Interventions: Device: Ambu AuraGain evaluation; Device: LMA Supreme evaluation; Procedure: Laparoscopic surgery

• Registration Number: NCT02511652
• Lead Sponsor: Hospital Clinic of Barcelona

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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Supreme	Laparoscopic surgery	Insertion of the supraglottic device and evaluation of its clinical performance
Ambu AuraGain	Ambu AuraGain evaluation	Insertion of the supraglottic device and evaluation of its clinical performance
Ambu AuraGain	Laparoscopic surgery	Insertion of the supraglottic device and evaluation of its clinical performance
LMA Supreme	LMA Supreme evaluation	Insertion of the supraglottic device and evaluation of its clinical performance

Primary Outcome Measures

Name	Time	Method
Airway seal pressure	At 15 minutes	Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.

Secondary Outcome Measures

Name	Time	Method
Ease of insertion of the device	Baseline	Time needed to insert the device
Change in Quality of ventilation	At baseline and at 15, 30 and 60 minutes	number of manoeuvres/corrections required
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

Trial Locations

Locations (1)

Ambulatory Surgery, Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain