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Completed

NCT Number: NCT02511652

Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

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.

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Key information

Conditions

Laparoscopy Airway Management Supraglottic Airway Devices

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatory Surgery, Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

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:

  • 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.
  • 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.
  • 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).
  • Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
  • 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.
  • 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%)

  • Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambu AuraGain evaluation

Device

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

LMA Supreme evaluation

Device

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

Laparoscopic surgery

Procedure

Gynecologic laparoscopic surgery in the trendelemburg position

Primary outcomes

  1. Airway seal pressure

    Time frame: At 15 minutes

    Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.

Secondary outcomes

  1. Ease of insertion of the device

    Time frame: Baseline

    Time needed to insert the device

  2. Change in Quality of ventilation

    Time frame: At baseline and at 15, 30 and 60 minutes

    number of manoeuvres/corrections required

  3. Endoscopic view of glottic structures

    Time frame: 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)

  4. Gastric tube insertion

    Time frame: At 5 minutes

    Ease of passage of a gastric tube as: easy, difficult or impossible

  5. Incidence of perioperative complications

    Time frame: 2 hours

    number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Ambu A/S

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2015
Registry last updated
Feb 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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