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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal Tube | Experimental | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
|
| Laryngeal Mask Airway | Experimental | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotracheal Tube | Device | Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Laryngospasm | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Postanesthesia Recovery Times | After surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelley Dodson, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virigina Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8240471 | Background | Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3. doi: 10.1093/bja/70.1.30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endotracheal Tube | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
| FG001 | Laryngeal Mask Airway | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endotracheal Tube | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
| BG001 | Laryngeal Mask Airway | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Laryngospasm | Posted | Number | Participants | 2 years |
|
|
No adverse events collected
No adverse events collected.
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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 | Endotracheal Tube | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Baldassari | Eastern Virginia Medical School | 7576689853 | baldassc@yahoo.com |
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| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
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| Laryngeal mask airway | Device | Randomized to either Laryngeal mask airway or endotracheal tube |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Postanesthesia Recovery Times | Posted | Mean | Standard Deviation | minutes | After surgery |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Laryngeal Mask Airway | Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway. | 0 | 0 | 0 | 0 |
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| D008397 |
| Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |