Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

NCT ID: NCT02511652

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-12-31

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

Conditions

Laparoscopy; Airway Management; Supraglottic Airway Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ambu AuraGain

Insertion of the supraglottic device and evaluation of its clinical performance

Group Type: ACTIVE_COMPARATOR

Ambu AuraGain evaluation

Intervention Type: DEVICE

Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

Laparoscopic surgery

Intervention Type: PROCEDURE

Gynecologic laparoscopic surgery in the trendelemburg position

LMA Supreme

Insertion of the supraglottic device and evaluation of its clinical performance

Group Type: ACTIVE_COMPARATOR

LMA Supreme evaluation

Intervention Type: DEVICE

Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

Laparoscopic surgery

Intervention Type: PROCEDURE

Gynecologic laparoscopic surgery in the trendelemburg position

Interventions

Ambu AuraGain evaluation

Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

Intervention Type: DEVICE

LMA Supreme evaluation

Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

Intervention Type: DEVICE

Laparoscopic surgery

Gynecologic laparoscopic surgery in the trendelemburg position

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ambu A/S

INDUSTRY

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Ana M Lopez

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana M Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Ambulatory Surgery, Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

HBarcelona

Identifier Type: -

Identifier Source: org_study_id