- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097771
Gastric Insufflation and Laryngeal Mask Airway
November 18, 2014 updated by: Lionel Bouvet
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lionel Bouvet
- Phone Number: +33 4 72 11 69 88
- Email: lionel.bouvet@chu-lyon.fr
Study Locations
-
-
-
Lyon, France, 69003
- Recruiting
- Hospices Civils de Lyon
-
Contact:
- Bouvet
- Phone Number: + 33 4 72 11 69 88
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA 1 or 2
- Age > 18 yrs
- Use of laryngeal mask airway required
Exclusion Criteria:
- risk of pulmonary aspiration of gastric contents
- Contraindication for the use of laryngeal mask airway
- Tracheal intubation required
- Patient's refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LMA SupremeTM
|
|
Sham Comparator: Ambu AuraOnce
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of gastric insufflation
Time Frame: during pulmonary ventilation through the laryngeal mask airway
|
during pulmonary ventilation through the laryngeal mask airway
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
July 1, 2015
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
March 21, 2014
First Submitted That Met QC Criteria
March 24, 2014
First Posted (Estimate)
March 27, 2014
Study Record Updates
Last Update Posted (Estimate)
November 19, 2014
Last Update Submitted That Met QC Criteria
November 18, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013-A01852-43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Insufflation
-
Diskapi Teaching and Research HospitalRecruitingGastric Insufflation | Difficult Mask VentilationTurkey
-
Universidad de AntioquiaUnknownGastric InsufflationColombia
-
SMG-SNU Boramae Medical CenterNot yet recruitingGastric Insufflation
-
Kasr El Aini HospitalRecruitingGastric Insufflation | Mask Ventilation | Gastric UltrasonographyEgypt
-
Warren BishopCompleted
-
Örebro University, SwedenCompletedRegurgitation | Air InsufflationSweden
-
National Taiwan University HospitalCompleted
-
Chang Gung Memorial HospitalCompletedCarbon Dioxide Insufflation During Colonoscopy
-
Kasr El Aini HospitalRecruitingObese | Gastric Insufflation | Positive End Expiratory Pressure | Face-mask VentilationEgypt
-
Zhongshan Hospital Xiamen UniversityActive, not recruitingColonoscopy | Gastrointestinal Microbiome | Appendix | Carbon Dioxide InsufflationChina
Clinical Trials on LMA SupremeTM
-
Schulthess KlinikKrankenhaus BozenUnknown
-
Jason BryantCompletedIntracuff PressureUnited States
-
National Taiwan University HospitalCompletedthe Influence of Oropharyngeal Leak Pressure and Sealing Between the Mask and Vocal Cord During Changing Patient's Head and Neck PositionTaiwan
-
Dr.Mahak MehtaCompletedProseal LMA vs Air-Q LMA vs Ambu AurGain LMA
-
Umraniye Education and Research HospitalCompleted
-
Prince of Songkla UniversityUnknownInadequate or Impaired Breathing Pattern or VentilationThailand
-
Medical University InnsbruckCompleted
-
Inonu UniversityCompletedAirway Complication of AnaesthesiaTurkey
-
University of MalayaCompletedA Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kgLaryngeal Mask AirwayMalaysia
-
King Saud UniversityCompleted