Gastric InsufflationNCT02097771
Gastric Insufflation and Laryngeal Mask Airway
A study testing LMA SupremeTM and AuraOnceTM in people with Gastric Insufflation, run by Lionel Bouvet at 1 site in France.
Trial summary
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Gastric Insufflation
- What is being tested?
- LMA SupremeTM and AuraOnceTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1 or 2
- Age > 18 yrs
- Use of laryngeal mask airway required
Who cannot join
- risk of pulmonary aspiration of gastric contents
- Contraindication for the use of laryngeal mask airway
- Tracheal intubation required
- Patient's refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69003
Bouvet, + 33 4 72 11 69 88
About this study
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM
- Conditions
- Gastric Insufflation
- Being tested
- LMA SupremeTM, AuraOnceTM
- Keywords
- laryngeal mask airway ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA SupremeTMDevice
AuraOnceTMDevice
| Study group | Role | What they receive |
|---|---|---|
| LMA SupremeTM | Active comparator | Not described Receives: Device: LMA SupremeTM |
| Ambu AuraOnce | Sham comparator | Not described Receives: Device: AuraOnceTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of gastric insufflation
Measured: during pulmonary ventilation through the laryngeal mask airway
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric InsufflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Lionel Bouvet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lionel Bouvet, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097771
- Sponsor's protocol ID
- 2013-A01852-43
- Status last verified
- Nov 2014
- First submitted
- 21 Mar 2014
- Last updated
- 19 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Insufflation and Laryngeal Mask Airway
- ClinicalTrials.gov ID
- NCT02097771
- Acronym / sponsor ID
- 2013-A01852-43
- Conditions
- Gastric Insufflation
- Keywords
- laryngeal mask airway ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Lionel BouvetUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the incidence of gastric insufflation between two kinds of laryngeal masks airways: LMA SupremeTM vs Ambu AuraOnceTM
Study design
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMA SupremeTM | Active comparator | Device: LMA SupremeTM |
| Ambu AuraOnce | Sham comparator | Device: AuraOnceTM |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1 or 2
- Age > 18 yrs
- Use of laryngeal mask airway required
Key exclusion criteria (4 listed)
- risk of pulmonary aspiration of gastric contents
- Contraindication for the use of laryngeal mask airway
- Tracheal intubation required
- Patient's refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMA SupremeTM | Device | LMA SupremeTM |
| AuraOnceTM | Device | Ambu AuraOnce |
Primary outcome
incidence of gastric insufflation
Time frame: during pulmonary ventilation through the laryngeal mask airway
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LMA SupremeTM and AuraOnceTM in people with Gastric Insufflation, run by Lionel Bouvet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lionel Bouvet (+33 4 72 11 69 88, lionel.bouvet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of gastric insufflation (time frame: during pulmonary ventilation through the laryngeal mask airway). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.