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

Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02570269

Enrollment

Registered

2015-10-07

Start date

2015-12-31

Completion date

2016-03-31

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Anesthesia Outcome

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.

Interventions

PROCEDURESlotted Guedeltubus

Fiberoptic Intubation

PROCEDUREAuraGain

Fiberoptic Intubation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Intubation time	Intraoperative	Time to complete the Intubation in seconds

Secondary

Measure	Time frame	Description
Esophagal Intubation attempts	Intraoperative	The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...)
Resistance measurement of the Insertion as assessed by a four point scoring system	Intraoperative	1/2/3/4
Intubation attempts	Intraoperative	The number of intubation attempts will be recorded (eg 1, 2, 3...)
Pain after Intubation as assessed by a Numeric Rating Scale	Intraoperative/2h postoperative/24h postoperative	mild/moderate/severe
AE/Complications	Intraoperative/postoperative until 24h	Occuring AE/Complications will be recorded
Position of the mask as assessed by the Brimacombe Score	Intraoperative	4/3/2/1

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026