Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511652
• Other study ID #: HBarcelona
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: February 19, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Management
• Laparoscopy
• Supraglottic Airway Devices

Intervention

Device:
• Ambu AuraGain evaluation
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
• LMA Supreme evaluation
Evaluation of clinical performance in terms of Insertion, ventilation, position and complications

Procedure:
• Laparoscopic surgery
Gynecologic laparoscopic surgery in the trendelemburg position

Locations

Country	Name	City	State
Spain	Ambulatory Surgery, Hospital Clinic de Barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	AMBU

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway seal pressure	Maximum airway pressure that the device can achieve without oropharyngeal leak of gas.	At 15 minutes	Yes
Secondary	Ease of insertion of the device	Time needed to insert the device	Baseline	Yes
Secondary	Change in Quality of ventilation	number of manoeuvres/corrections required	At baseline and at 15, 30 and 60 minutes	Yes
Secondary	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	Yes
Secondary	Gastric tube insertion	Ease of passage of a gastric tube as: easy, difficult or impossible	At 5 minutes	Yes
Secondary	Incidence of perioperative complications	number of patients with adverse events: Airway obstruction, desaturation, Aspiration, oropharyngeal trauma, sore throat	2 hours	Yes