Adverse Effect of Unspecified General AnestheticsPhase 4NCT00836095
Comparison of ProSeal Laryngeal Mask Airway to Laryngeal Mask Airway Supreme
A Phase 4 study testing Supreme Laryngeal mask airway and Proseal laryngeal mask airway in people with Adverse Effect of Unspecified General Anesthetics, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adverse Effect of Unspecified General Anesthetics
- What is being tested?
- Supreme Laryngeal mask airway and Proseal laryngeal mask airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 75 years
- ASA I and II
- Mallampatti class: I and II
- Thyromental distance > than 6.5 cm
- Interincisor distance > than 3 cm
- BMI < 35 Kg/m2
- Patients scheduled to undergo anesthesia with an LMA for minor extraperitoneal surgical procedures in supine position
Who cannot join
- Weight < 50 kg
- BMI > 35 Kg/m2
- Pregnant patients
- Known or expected difficult airway
- Patients with active, untreated and unresolved gastroesophageal reflux
- Esophageal pathology, pulmonary pathology
- Laparoscopic procedures
- ENT procedures, gastrointestinal procedures, intraperitoneal surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
PennState Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients
Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.
The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.
- Being tested
- Supreme Laryngeal mask airway, Proseal laryngeal mask airway
- Keywords
- laryngeal mask, proseal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supreme Laryngeal mask airwayDevice
Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
Proseal laryngeal mask airwayDevice
Proseal is a multiple use, variant of the laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| Supreme LMA | Other | Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. Receives: Device: Supreme Laryngeal mask airway |
| Proseal LMA | Active comparator | Proseal is a multiple use, variant of the laryngeal mask airway.
The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. Receives: Device: Proseal laryngeal mask airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insertion Time
The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.
Measured: During intubation of the patient
Secondary outcomes (1)
Insertion Success Rate
Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified.
Measured: During intubation of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse Effect of Unspecified General AnestheticsStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Vaida, Penn State University
- Investigators
- Sonia J Vaida, MD, Principal investigator, Penn State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836095
- Sponsor's protocol ID
- IRB 29920
- Status last verified
- Mar 2016
- First submitted
- 2 Feb 2009
- Last updated
- 15 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the ProSeal Laryngeal Mask Airway With the Laryngeal Mask Airway Supreme in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT00836095
- Acronym / sponsor ID
- IRB 29920
- Keywords
- laryngeal mask, proseal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laryngeal mask airway is a widely used device in routine anesthesia for airway management during surgery. It consists of a tube with an inflatable cuff that is inserted into the mouth after induction of general anesthesia. The Proseal Laryngeal mask airway and the Laryngeal mask airway Supreme are two variants of the Laryngeal mask airway. The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.
The research is being done to compare two variants of the laryngeal mask airway: the Proseal laryngeal mask airway and the Laryngeal mask airway Supreme. This study will determine if the newer model, the Laryngeal mask airway Supreme, is easier to insert and is better positioned than the older model, the Proseal laryngeal mask airway. Both models are approved for use by the FDA, and are routinely used to assure the airway during general anesthesia.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supreme LMA | Other | Device: Supreme Laryngeal mask airwaySupreme Laryngeal mask airway is a new, single use laryngeal mask airway variant. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. |
| Proseal LMA | Active comparator | Device: Proseal laryngeal mask airwayProseal is a multiple use, variant of the laryngeal mask airway. The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 - 75 years
- ASA I and II
- Mallampatti class: I and II
- Thyromental distance > than 6.5 cm
- Interincisor distance > than 3 cm
Key exclusion criteria (8 listed)
- Weight < 50 kg
- BMI > 35 Kg/m2
- Pregnant patients
- Known or expected difficult airway
- Patients with active, untreated and unresolved gastroesophageal reflux
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 |
|---|---|---|
| Supreme Laryngeal mask airwaySupreme Laryngeal mask airway is a new, single use laryngeal mask airway variant | Device | Supreme LMA |
| Proseal laryngeal mask airwayProseal is a multiple use, variant of the laryngeal mask airway | Device | Proseal LMA |
Primary outcome
Insertion Time
Time frame: During intubation of the patient
The insertion time will be the measured time that it takes the anesthesiologist to insert the airway and verify ventilation of the patient's airway. Data reported will be time in seconds ± the standard deviation.
1 secondary outcome
Insertion Success Rate
Time frame: During intubation of the patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Sonia J Vaida, MD principal investigator
Penn State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supreme Laryngeal mask airway and Proseal laryngeal mask airway in people with Adverse Effect of Unspecified General Anesthetics, run by Milton S. Hershey Medical Center at 1 site in United States.
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 7 inclusion and 8 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 15 Apr 2016. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Time (time frame: During intubation of the patient). 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 15 Apr 2016.