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

Not Applicable

Completed

• Conditions: Adverse Anesthesia Outcome
• Interventions: Procedure: Slotted Guedeltubus; Procedure: AuraGain

• Registration Number: NCT02570269
• Lead Sponsor: Schulthess Klinik

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-07
• Study Start: 2015-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slotted Guedeltubus	Slotted Guedeltubus	The patient will get a fiberoptic intubation via the slotted Guedeltubus
AuraGain	AuraGain	The patient will get a fiberoptic Intubation via the AuraGain larynxmask

Primary Outcome Measures

Name	Time	Method
Intubation time	Intraoperative	Time to complete the Intubation in seconds

Secondary Outcome Measures

Name	Time	Method
Position of the mask as assessed by the Brimacombe Score	Intraoperative	4/3/2/1
Esophagal Intubation attempts	Intraoperative	The number of esophagal 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
Intubation attempts	Intraoperative	The number of 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

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland