Adverse Effect of Unspecified General Anesthetics
Conditions
Keywords
laryngeal mask, proseal
Brief 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. 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 The laryngeal mask airway Supreme is a newer version of the laryngeal mask airway.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.
Interventions
Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant
Proseal is a multiple use, variant of the laryngeal mask airway
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Success Rate | During intubation of the patient | Insertion success rate will be reported as the number of patients for whom the airway device was successfully inserted and ventilation was verified. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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 | 30 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 |
Baseline characteristics
| Characteristic | Supreme LMA | Proseal LMA | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 14 | 41 years STANDARD_DEVIATION 14 | 45 years STANDARD_DEVIATION 14 |
| Sex: Female, Male Female | 14 Participants | 18 Participants | 32 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 30 |
| serious Total, serious adverse events | 0 / 22 | 0 / 30 |
Outcome results
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.
Time frame: During intubation of the patient
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supreme LMA | Insertion Time | 26 seconds | Standard Deviation 10 |
| Proseal LMA | Insertion Time | 18 seconds | Standard Deviation 6 |
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.
Time frame: During intubation of the patient
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supreme LMA | Insertion Success Rate | 22 Number of successful airway insertions |
| Proseal LMA | Insertion Success Rate | 27 Number of successful airway insertions |