Laryngeal Mask Airway, Tonsillectomy
Conditions
Brief summary
The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.
Interventions
DEVICELaryngeal mask airway
Randomized to either Laryngeal mask airway or endotracheal tube
DEVICEEndotracheal Tube
Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Laryngospasm | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Postanesthesia Recovery Times | After surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endotracheal Tube Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. | 71 |
| Laryngeal Mask Airway Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. | 60 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 12 |
Baseline characteristics
| Characteristic | Laryngeal Mask Airway | Endotracheal Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 60 Participants | 71 Participants | 131 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.69 years STANDARD_DEVIATION 2.3 | 5.5 years STANDARD_DEVIATION 2.5 | 5.6 years STANDARD_DEVIATION 2.4 |
| Region of Enrollment United States | 60 participants | 71 participants | 131 participants |
| Sex: Female, Male Female | 25 Participants | 31 Participants | 56 Participants |
| Sex: Female, Male Male | 35 Participants | 40 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 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Laryngospasm
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Endotracheal Tube | Number of Participants With Laryngospasm | 8 Participants |
| Laryngeal Mask Airway | Number of Participants With Laryngospasm | 6 Participants |
Secondary
Postanesthesia Recovery Times
Time frame: After surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Endotracheal Tube | Postanesthesia Recovery Times | 95.59 minutes | Standard Deviation 77.72 |
| Laryngeal Mask Airway | Postanesthesia Recovery Times | 83.50 minutes | Standard Deviation 58.91 |