NCT02820792

Brief Summary

The LMA ProtectorTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM in paralyzed, anesthetized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

June 29, 2016

Last Update Submit

January 25, 2017

Conditions

Airway Morbidity

Outcome Measures

Primary Outcomes (1)

  • oropharyngeal leak pressure

    Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).

    5 min

Secondary Outcomes (1)

  • anatomic position

    5 min

Study Arms (2)

LMA ProtectorTM

ACTIVE COMPARATOR

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Procedure: function testsDevice: LMA ProtectorTM

Ambu AuraGainTM

ACTIVE COMPARATOR

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Procedure: function testsDevice: Ambu AuraGainTM

Interventions

function testsPROCEDURE

function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion

Ambu AuraGainTMLMA ProtectorTM
LMA ProtectorTMDEVICE
LMA ProtectorTM
Ambu AuraGainTMDEVICE
Ambu AuraGainTM

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1 or 2
  • Age 19-65 yr
  • Written informed consent

You may not qualify if:

  • Difficult airway
  • Non fasted
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

Christian Keller MD, M.Sc.

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Platelet Function Tests

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Berthold Moser, MD MBA

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 20, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)