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

Adverse Anesthesia Outcome Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570269
• Other study ID #: Schulthess_Anä_6
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome

Intervention

Procedure:
• AuraGain
Fiberoptic Intubation
• Slotted Guedeltubus
Fiberoptic Intubation

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

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