IntubationNCT00402870
Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
A study testing ProSeal LMA and ProSeal LMA, Tracheal Tube in people with Intubation, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intubation
- What is being tested?
- ProSeal LMA and ProSeal LMA, Tracheal Tube
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2007to Sep 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 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- ASA I-II
- Age 18-75
- Elective laparoscopic surgery
Who cannot join
- Known or predicted difficult airway
- Oropharyngeal pathology
- Mouth opening < 3.0 cm
- A body mass index > 35 kg m-2
- Increased risk of aspiration
- Inability to communicate or understand the visual analogue scale
- Analgesics within 24 hours of surgery
Trial locations and contacts
1 site in 1 country.
About this study
The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.
- Conditions
- Intubation
- Being tested
- ProSeal LMA, ProSeal LMA, Tracheal Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProSeal LMADevice
ProSeal LMA vs Tracheal Tube
ProSeal LMA, Tracheal TubeDevice
ProSeal LMA vs Tracheal Tube
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402870
- Sponsor's protocol ID
- 2006-95
- Status last verified
- Dec 2007
- First submitted
- 20 Nov 2006
- Last updated
- 4 Dec 2007
- Results posted
- No
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
- Postoperative Analgesic Requirements for the ProSeal Laryngeal Mask Airway Versus the Tracheal Tube in Females Undergoing Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT00402870
- Acronym / sponsor ID
- 2006-95
- Conditions
- Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Nov 2006 (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 is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- ASA I-II
- Age 18-75
- Elective laparoscopic surgery
Key exclusion criteria (7 listed)
- Known or predicted difficult airway
- Oropharyngeal pathology
- Mouth opening < 3.0 cm
- A body mass index > 35 kg m-2
- Increased 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 LMAProSeal LMA vs Tracheal Tube | Device | – |
| ProSeal LMA, Tracheal TubeProSeal LMA vs Tracheal Tube | Device | – |
Primary outcome
Postoperative analgesia
Time frame: 24 hrs
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.
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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, Medical University Innsbruck
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 and ProSeal LMA, Tracheal Tube in people with Intubation, 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 7 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?
Postoperative analgesia (time frame: 24 hrs). 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 4 Dec 2007.