Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position

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.

Study Overview

• Status: Completed
• Conditions: Airway Management; Laparoscopy; Supraglottic Airway Devices
• Intervention / Treatment: Device: Ambu AuraGain evaluation; Procedure: Laparoscopic surgery; Device: LMA Supreme evaluation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Ambulatory Surgery, Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ambu AuraGain; Insertion of the supraglottic device and evaluation of its clinical performance	Device: Ambu AuraGain evaluation; Evaluation of clinical performance in terms of Insertion, ventilation, position and complications; Procedure: Laparoscopic surgery; Gynecologic laparoscopic surgery in the trendelemburg position
Active Comparator: LMA Supreme; Insertion of the supraglottic device and evaluation of its clinical performance	Procedure: Laparoscopic surgery; Gynecologic laparoscopic surgery in the trendelemburg position; Device: LMA Supreme evaluation; Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway seal pressure	Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.	At 15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion of the device	Time needed to insert the device	Baseline
Change in Quality of ventilation	number of manoeuvres/corrections required	At baseline and at 15, 30 and 60 minutes
Endoscopic view of glottic structures	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)	At 15 minutes
Gastric tube insertion	Ease of passage of a gastric tube as: easy, difficult or impossible	At 5 minutes
Incidence of perioperative complications	number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat	2 hours

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Ambu A/S
• Investigators: Principal Investigator: Ana M Lopez, MD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 19, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HBarcelona