Difficult AirwayNCT00500916
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
A study testing ProSeal LMA in people with Difficult Airway and Ventilation, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the… Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Difficult Airway, Ventilation
- What is being tested?
- ProSeal LMA
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2007to Dec 2007
- 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 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient
- 19-70 yr
- Body mass index <35 kg/m2
- Difficult airway
Who cannot join
- < 19 yr
- Body mass index >35 kg/m2
- Risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.
- Conditions
- Difficult Airway, Ventilation
- Being tested
- ProSeal LMA
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSeal LMADevice
GEB vs digital vs introducer tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion success rate
Measured: 5 min
Secondary outcomes (1)
Time to successful insertion
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startMar 2007
- Study completionDec 2007
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 Difficult AirwayStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Investigators
- Christian Keller, MD, M.Sc., Principal investigator, Dept of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500916
- Sponsor's protocol ID
- UN2532
- Status last verified
- Dec 2007
- First submitted
- 11 Jul 2007
- Last updated
- 4 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Eschertzhuber S, Brimacombe J, Hohlrieder M, Stadlbauer KH, Keller C. Gum elastic bougie-guided insertion of the ProSeal laryngeal mask airway is superior to the digital and introducer tool techniques in patients with simulated difficult laryngoscopy using a rigid neck collar. Anesth Analg. 2008 Oct;107(4):1253-6. doi: 10.1213/ane.0b013e31817f0def.
PubMed 18806036
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
- ClinicalTrials.gov ID
- NCT00500916
- Acronym / sponsor ID
- UN2532
- Conditions
- Difficult Airway, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 0 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 13 Jul 2007 (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.
The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA, or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100) respectively, with the main causes of insertion difficulty being impaction at the back of the mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB) placed in the esophagus to guide the PLMA around the back of the mouth and into its correct position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive insertions. In the following study, we test the hypothesis that GEB-guided insertion is more frequently successful than the digital and IT techniques in patients with difficult airway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient
- 19-70 yr
- Body mass index <35 kg/m2
- Difficult airway
Key exclusion criteria (3 listed)
- < 19 yr
- Body mass index >35 kg/m2
- Risk of aspiration
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 |
|---|---|---|
| ProSeal LMAGEB vs digital vs introducer tool | Device | – |
Primary outcome
Insertion success rate
Time frame: 5 min
1 secondary outcome
Time to successful insertion
Time frame: 5 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 4 Dec 2007.
- Derived from this study: PubMed 18806036Eschertzhuber S, Brimacombe J, Hohlrieder M, Stadlbauer KH, Keller C. Gum elastic bougie-guided insertion of the ProSeal laryngeal mask airway is superior to the digital and introducer tool techniques in patients with simulated difficult laryngoscopy using a rigid neck collar. Anesth Analg. 2008 Oct;107(4):1253-6. doi: 10.1213/ane.0b013e31817f0def.
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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.
Christian Keller, MD, M.Sc. principal investigator
Dept of Anesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProSeal LMA in people with Difficult Airway and Ventilation, run by Medical University Innsbruck at 1 site in Austria.
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 4 inclusion and 3 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 4 Dec 2007. 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 Austria. 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?
Insertion success rate (time frame: 5 min). 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 NCT00500916, 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 4 Dec 2007.