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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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supreme Laryngeal mask airway | Device | Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During intubation of the patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During intubation of the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonia J Vaida, MD | Penn State | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PennState Hershey Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supreme LMA | Supreme Laryngeal mask airway: The 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. |
| FG001 | Proseal LMA | Proseal laryngeal mask airway: The 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supreme LMA | 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. Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | During intubation of the patient |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Supreme LMA | 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. Both airway devices will be blindly inserted by an experienced attending anesthesiologist. Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sonia Vaida MD, Professor of Anesthesiology | Penn State Milton S. Hershey Medical Center | 7175318433 | svaida@hmc.psu.edu |
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| Proseal laryngeal mask airway | Device | Proseal is a multiple use, variant of the laryngeal mask airway |
|
| Proseal LMA |
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 laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | 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. | Posted | Number | Number of successful airway insertions | During intubation of the patient |
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| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Proseal LMA | 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. Both airway devices will be blindly inserted by an experienced attending anesthesiologist. Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway | 0 | 30 | 0 | 30 |
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