NCT02511652

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

July 20, 2015

Last Update Submit

February 19, 2016

Conditions

LaparoscopyAirway ManagementSupraglottic Airway Devices

Outcome Measures

Primary Outcomes (1)

  • Airway seal pressure

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

    At 15 minutes

Secondary Outcomes (5)

  • Ease of insertion of the device

    Baseline

  • Change in Quality of ventilation

    At baseline and at 15, 30 and 60 minutes

  • Endoscopic view of glottic structures

    At 15 minutes

  • Gastric tube insertion

    At 5 minutes

  • Incidence of perioperative complications

    2 hours

Study Arms (2)

Ambu AuraGain

ACTIVE COMPARATOR

Insertion of the supraglottic device and evaluation of its clinical performance

Device: Ambu AuraGain evaluationProcedure: Laparoscopic surgery

LMA Supreme

ACTIVE COMPARATOR

Insertion of the supraglottic device and evaluation of its clinical performance

Device: LMA Supreme evaluationProcedure: Laparoscopic surgery

Interventions

Ambu AuraGain evaluationDEVICE

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

Ambu AuraGain
LMA Supreme evaluationDEVICE

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

LMA Supreme
Laparoscopic surgeryPROCEDURE

Gynecologic laparoscopic surgery in the trendelemburg position

Ambu AuraGainLMA Supreme

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatory Surgery, Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ana M Lopez, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 30, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

ES(1)