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.

Schulthess Klinik1 site in 1 country94 target enrollmentDecember 2015

ConditionsAdverse Anesthesia Outcome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adverse Anesthesia Outcome
Sponsor: Schulthess Klinik
Enrollment: 94
Locations: 1
Primary Endpoint: Intubation time
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

March 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Schulthess Klinik

Responsible Party

Principal Investigator

Berthold Moser

Principal Investigator

Schulthess Klinik

Eligibility Criteria

Inclusion Criteria

•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

Outcomes

Primary Outcomes

Intubation time

Time Frame: Intraoperative

Time to complete the Intubation in seconds

Secondary Outcomes

Esophagal Intubation attempts(Intraoperative)
Pain after Intubation as assessed by a Numeric Rating Scale(Intraoperative/2h postoperative/24h postoperative)
AE/Complications(Intraoperative/postoperative until 24h)
Intubation attempts(Intraoperative)
Position of the mask as assessed by the Brimacombe Score(Intraoperative)
Resistance measurement of the Insertion as assessed by a four point scoring system(Intraoperative)