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Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus

S

Schulthess Klinik

Status

Completed

Conditions

Adverse Anesthesia Outcome

Treatments

Procedure: Slotted Guedeltubus
Procedure: AuraGain

Study type

Interventional

Funder types

Other

Identifiers

NCT02570269
Schulthess_Anä_6

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

94 participants in 2 patient groups, including a placebo group

AuraGain
Active Comparator group
Description:
The patient will get a fiberoptic Intubation via the AuraGain larynxmask
Treatment:
Procedure: AuraGain
Slotted Guedeltubus
Placebo Comparator group
Description:
The patient will get a fiberoptic intubation via the slotted Guedeltubus
Treatment:
Procedure: Slotted Guedeltubus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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