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Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

NCT02511652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-02-22

No results posted yet for this study

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.

Conditions

  • Laparoscopy
  • Airway Management
  • Supraglottic Airway Devices

Interventions

DEVICE

Ambu AuraGain evaluation

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

DEVICE

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

Sponsors & Collaborators

  • Ambu A/S

    collaborator INDUSTRY

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Ana M Lopez, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02511652 on ClinicalTrials.gov