Airway RemodelingOSSGANCT02566291
Observational Study With Investigation of Two Second Generation Laryngeal Masks
An observational study of Airway Remodeling, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Remodeling
- What is being tested?
- Success
- Type of treatment
- Medical device
- How many people
- 364 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Mar 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria: Age > 18 Years informed consent elective surgery undergoing general anesthesia non-pregnant
Who may be able to join
- Age ≥ 18 Years
- No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
Show all 9Show fewer
- ASA classification> 3
- situations where the possibility of accumulated gastric contents
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology;
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.
Read the detailed description
After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.
- Conditions
- Airway Remodeling
- Being tested
- Success
- Keywords
- laryngeal mask, airway leakage, airway morbidity
- Medical subject headings
- Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuccessDevice
Success rate and time for insertion
| Study group | Role | What they receive |
|---|---|---|
| Supreme Group | Measuring Success rate and Insertion Time Receives: Device: Success | |
| Gain Group | Measuring Success rate and Insertion Time Receives: Device: Success |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
overall and first attempt success rate
Measured: 70-98 Percent
Secondary outcomes (2)
Time for insertion
Measured: 5-120 seconds
Leakage in ml.min
Measured: 0-300 ml.min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway RemodelingStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc MK Kriege, MD, Principal investigator, University JG, Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566291
- Sponsor's protocol ID
- SGA 2014
- Acronym
- OSSGA
- Status last verified
- Jan 2017
- First submitted
- 30 Sep 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Russo SG, Cremer S, Galli T, Eich C, Brauer A, Crozier TA, Bauer M, Strack M. Randomized comparison of the i-gel, the LMA Supreme, and the Laryngeal Tube Suction-D using clinical and fibreoptic assessments in elective patients. BMC Anesthesiol. 2012 Aug 7;12:18. doi: 10.1186/1471-2253-12-18.
PubMed 22871204
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supraglottic Airways LMA Supreme and Ambu AuraGain in Clinical Practice: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02566291
- Acronym / sponsor ID
- OSSGA / SGA 2014
- Conditions
- Airway Remodeling
- Keywords
- laryngeal mask, airway leakage, airway morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Oct 2015 (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.
In a observational study the second-generation laryngeal masks LMA Supreme and Ambu AuraGain are investigated.
Detailed description
After approval from the local ethics committee, data were collected in a prospective, non- randomised study over a three-month period. When contra-indications for laryngeal mask use were absent anaesthesiologists used either Supreme (Teleflex Medical GmbH, Germany) or Gain (Ambu GmbH, Germany). Endpoints were the success rate and time to insertion.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme Group | – | Device: SuccessMeasuring Success rate and Insertion Time |
| Gain Group | – | Device: SuccessMeasuring Success rate and Insertion Time |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: Age > 18 Years informed consent elective surgery undergoing general anesthesia non-pregnant
Key inclusion criteria (5 listed)
- Age ≥ 18 Years
- No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Key exclusion criteria (9 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
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 |
|---|---|---|
| SuccessSuccess rate and time for insertion | Device | Gain Group, Supreme Group |
Primary outcome
Success rate
Time frame: 70-98 Percent
overall and first attempt success rate
2 secondary outcomes
Time for insertion
Time frame: 5-120 seconds
Leakage in ml.min
Time frame: 0-300 ml.min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Results publication: PubMed 22871204Russo SG, Cremer S, Galli T, Eich C, Brauer A, Crozier TA, Bauer M, Strack M. Randomized comparison of the i-gel, the LMA Supreme, and the Laryngeal Tube Suction-D using clinical and fibreoptic assessments in elective patients. BMC Anesthesiol. 2012 Aug 7;12:18. doi: 10.1186/1471-2253-12-18.
- Individual participant dataSharing planned: No
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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.
Marc MK Kriege, MD principal investigator
University JG, Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Remodeling, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 24 Jan 2017. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (time frame: 70-98 Percent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566291, which also lists 1 linked publication.
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 24 Jan 2017.