Laryngeal Masks
Conditions
Keywords
LMA Flexible
Brief summary
The 90° rotation technique is known to improve the success rate of conventional LMA but its effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could increase the first attempt success rate of the insertion of LMA FlexibleTM compared to standard technique.
Detailed description
One hundred and sixteen adult patients undergoing breast surgery were randomized to the two insertion techniques. The ease of insertion was assessed by the success rate at the first attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after insertion. Postoperative complications were checked.
Interventions
PROCEDURE90° rotational technique
the LMA FlexibleTM was rotated counter-clockwise through 90°
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists class I - II * Scheduled for elective breast surgery under general anaesthesia using LMA FlexibleTM
Exclusion criteria
* known difficult airway * mouth opening less than 2.5 cm * limited extension of neck * recent sore throat * gastroesophageal reflux disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Attempt Success Rate | at induction | the first attempt success rate of insertion of LMA FlexibleTM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion Time | at induction | time from passed mouth of the device to the effective ventilation after inflation of the cuff |
| Oropharyngeal Leak Pressure | at induction | audible leak during manual ventilation at mouth |
| Number of Participants With Blood Staining on the Laryngeal Mask Airway | post op 1min | Number of Participants with blood staining on the laryngeal mask airway. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard In the neck flexed and the head extended position, hold mask like a pen with the index finger placed anteriorly at the junction of the cuff and tube, push the mask backwards maintaining pressure against the palate until resistance is felt. | 63 |
| Rotational After insertion of the entire cuff inside the mouth, the LMA FlexibleTM was rotated counter-clockwise through 90° and was advanced through the right side of the tongue until the resistance was felt, and then was returned back in the hypopharynx.
90° rotational technique: the LMA FlexibleTM was rotated counter-clockwise through 90° | 66 |
| Total | 129 |
Baseline characteristics
| Characteristic | Standard | Rotational | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 4 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 62 Participants | 124 Participants |
| Sex: Female, Male Female | 63 Participants | 66 Participants | 129 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 63 | 0 / 66 |
| other Total, other adverse events | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
First Attempt Success Rate
the first attempt success rate of insertion of LMA FlexibleTM
Time frame: at induction
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard | First Attempt Success Rate | 59 Participants |
| Rotational | First Attempt Success Rate | 65 Participants |
Secondary
Insertion Time
time from passed mouth of the device to the effective ventilation after inflation of the cuff
Time frame: at induction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard | Insertion Time | 10.5 seconds | Standard Deviation 4.7 |
| Rotational | Insertion Time | 9.7 seconds | Standard Deviation 4.7 |
Secondary
Number of Participants With Blood Staining on the Laryngeal Mask Airway
Number of Participants with blood staining on the laryngeal mask airway.
Time frame: post op 1min
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard | Number of Participants With Blood Staining on the Laryngeal Mask Airway | 1 Participants |
| Rotational | Number of Participants With Blood Staining on the Laryngeal Mask Airway | 3 Participants |
Secondary
Oropharyngeal Leak Pressure
audible leak during manual ventilation at mouth
Time frame: at induction
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard | Oropharyngeal Leak Pressure | 19.8 cmH2O | Standard Deviation 4.9 |
| Rotational | Oropharyngeal Leak Pressure | 20.5 cmH2O | Standard Deviation 4.2 |