Elective Surgery, General Anesthesia
Conditions
Keywords
ProSeal Laryngeal Mask Airway, Rotational technique, Success rate, Postoperative complications
Brief summary
The purpose of this study is to compare two insertion techniques of large size ProSeal laryngeal mask airway. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.
Detailed description
ProSeal laryngeal mask airway is not easy to be inserted due to its larger cuff especially in Asian population. First-time insertion success rate was lower and more time was required to achieve an effective airway even in well-trained physician. A number of techniques have been described to improve the insertion success rate. However, these techniques are only recommended to be used as backup when the digital or introducer tool techniques fail. We hypothesized that insertion of ProSeal laryngeal mask airway with 90-degree rotation would reduce the contact surface between the device and pharyngeal wall and make it easy to advance the device over the smooth angle against the posterior pharyngeal wall.We compared the success rate and incidence of complication of the standard technique with the rotational technique.
Interventions
PROCEDUREInsertion fo ProSeal laryngeal mask airway
Insertion fo ProSeal laryngeal mask airway using each of Standard technique or Rotational technique
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
27 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status I-II
Exclusion criteria
* Predicted difficult airway * Mouth opening less than 2.5 cm * Present sore throat * High risk of aspiration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of Insertion at First Attempt | 5 minute |
Secondary
| Measure | Time frame |
|---|---|
| Insertion Time, Sealing Pressure and Complication | 5 min - 4 hours |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Technique Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual | 60 |
| Rotational Technique | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Rotational Technique | Standard Technique | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 52 Participants | 108 Participants |
| Age Continuous | 47.4 years STANDARD_DEVIATION 10.7 | 49.6 years STANDARD_DEVIATION 12.9 | 48.5 years STANDARD_DEVIATION 11.8 |
| Region of Enrollment Korea, Republic of | 60 participants | 60 participants | 120 participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 38 Participants | 37 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Success of Insertion at First Attempt
Time frame: 5 minute
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Technique | Success of Insertion at First Attempt | 50 participants |
| Rotational Technique | Success of Insertion at First Attempt | 60 participants |
Secondary
Insertion Time, Sealing Pressure and Complication
Time frame: 5 min - 4 hours