Ambu®AuraGain™ Versus I-gel® in Obese Patients
Prospective Randomized Comparison Between a Fiber Optic Intubation Via the Ambu® AuraGain ™ or the i-Gel® Laryngeal Mask Until a Complete Airway Protection in Obese Patients
1 other identifier
interventional
44
1 country
1
Brief Summary
The aim of this study is the randomized comparison of two laryngeal mask (Intersurgical i-gel® and Ambu®AuraGain™) in obese patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 12, 2017
CompletedStudy Start
First participant enrolled
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2017
CompletedJanuary 8, 2018
January 1, 2018
5 months
March 20, 2017
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of successful intubation
Measurement of a fiberoptic intubation with the laryngeal mask. Start: Insertion of the fiberoptic into the larynxmask until the intubation has been done and after the fiberoptic has been removed.
intraoperative
Secondary Outcomes (22)
Number of Insertions (of the laryngeal mask)
intraoperative
Time of insertion
intraoperative
Number of insertion attempts
intraoperative
Gastric volume
intraoperative
Positioning of the gastric probe
intraoperative
- +17 more secondary outcomes
Study Arms (2)
Ambu® AuraGain™
EXPERIMENTALIntervention with Ambu® AuraGain™Laryngeal Mask
Intersurgical i-gel®
ACTIVE COMPARATORIntervention with Intersurgical i-gel® Laryngeal Mask
Interventions
Eligibility Criteria
You may qualify if:
- ASA 1-3
- Shoulder-/Elbow-/Hip-/Knee- or Foot - Surgery
- Signed informed consent
- BMI \> 35kg/m2
You may not qualify if:
- Non-sober patients (last meal \<6 h)
- Symptomatic reflux disease
- Hiatus hernia
- Significant cardiovascular risk factors
- Severe COPD
- Gastric band or gastric bypass
- Disease which allows an accurate examination of the physicians (e.g. neuromuscular, mental, metabolic disease)
- Drug or drug abuse in the recent past
- Legal immaturity (incompetence)
- Acute disease, which calls into question the narcotic potential
- Patients with whom the use of a laryngeal mask is contraindicated or otherwise not possible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schulthess Klinik
Zurich, 8008, Switzerland
Related Publications (1)
Moser B, Keller C, Audige L, Dave MH, Bruppacher HR. Fiberoptic intubation of severely obese patients through supraglottic airway: A prospective, randomized trial of the Ambu(R) AuraGain laryngeal mask vs the i-gel airway. Acta Anaesthesiol Scand. 2019 Feb;63(2):187-194. doi: 10.1111/aas.13242. Epub 2018 Aug 8.
PMID: 30088266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Berthold Berthold, MD
Schulthess Klinik
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 20, 2017
First Posted
April 12, 2017
Study Start
April 20, 2017
Primary Completion
September 6, 2017
Study Completion
September 6, 2017
Last Updated
January 8, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share