NCT02570269

Brief Summary

The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

September 23, 2015

Last Update Submit

April 11, 2019

Conditions

Adverse Anesthesia Outcome

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Time to complete the Intubation in seconds

    Intraoperative

Secondary Outcomes (6)

  • Intubation attempts

    Intraoperative

  • Esophagal Intubation attempts

    Intraoperative

  • Resistance measurement of the Insertion as assessed by a four point scoring system

    Intraoperative

  • Position of the mask as assessed by the Brimacombe Score

    Intraoperative

  • Pain after Intubation as assessed by a Numeric Rating Scale

    Intraoperative/2h postoperative/24h postoperative

  • +1 more secondary outcomes

Study Arms (2)

AuraGain

ACTIVE COMPARATOR

The patient will get a fiberoptic Intubation via the AuraGain larynxmask

Procedure: AuraGain

Slotted Guedeltubus

PLACEBO COMPARATOR

The patient will get a fiberoptic intubation via the slotted Guedeltubus

Procedure: Slotted Guedeltubus

Interventions

AuraGainPROCEDURE

Fiberoptic Intubation

AuraGain
Slotted GuedeltubusPROCEDURE

Fiberoptic Intubation

Slotted Guedeltubus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18
  • ASA 1 -2
  • Surgery of the shoulder, elbow, hand, hip, knee or foot
  • Signed consent form

You may not qualify if:

  • Patients with expected difficulties regarding to the intubation
  • Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
  • Not sober
  • Increased risk of aspiration
  • BMI \> 35 kg/m2
  • Acute disease which could affect the suitability of the anesthesia
  • Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
  • Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
  • Drug abuse in the recent past
  • Legal incompetence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (1)

  • Moser B, Audige L, Keller C, Brimacombe J, Gasteiger L, Bruppacher HR. Flexible bronchoscopic intubation through the AuraGain laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Can J Anaesth. 2017 Nov;64(11):1119-1128. doi: 10.1007/s12630-017-0936-7. Epub 2017 Jul 17.

    PMID: 28718101DERIVED

Study Officials

  • Berthold Moser, MD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2015

First Posted

October 7, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 16, 2019

Record last verified: 2016-04

Locations

CH(1)