Clinical trial NCT02511652: Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery
Official title: Comparison of the Ambu AuraGain vs. LMA Supreme in Paralysed Patients Undergoing Gynecologic Laparoscopic Surgery in the Trendelemburg Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Airway Management
Supraglottic Airway Devices
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Ambu A/S
First posted: 2015-07-30
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Airway seal pressure
timeFrame: At 15 minutes
Secondary outcomes:
measure: Ease of insertion of the device
timeFrame: Baseline
measure: Change in Quality of ventilation
timeFrame: At baseline and at 15, 30 and 60 minutes
measure: Endoscopic view of glottic structures
timeFrame: At 15 minutes
measure: Gastric tube insertion
timeFrame: At 5 minutes
measure: Incidence of perioperative complications
timeFrame: 2 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Ambulatory Surgery, Hospital Clinic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Ana M Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: