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Esophagogastroduodenoscopy (EGD) is a relatively common procedure in pediatric patients undergoing evaluation for various gastrointestinal ailments. The procedure itself, with or without associated biopsies, is relatively short in length. Unlike adults, who regularly undergo this procedure with conscious sedation, children most often require general anesthesia. While safe and effective, endotracheal tracheal tube (ETT) intubation of children for EGD can result in delayed awakening and slow room turnover, particularly when intravenous medications are required for intubation. Laryngeal mask airway (LMA) is an alternative to intubation, which permits removal before full awakening.
Although considered a safe alternative to tracheal intubation in appropriate cases, disadvantages of the LMA have been reported including kinking, occluding view of the surgical field, failure of placement requiring tracheal intubation, aspiration of gastric contents, desaturation, and laryngospasm. The study was designed to determine whether use of an LMA for EGD could reduce operating room time, while providing satisfactory conditions for the endoscopist, and an equivalent side effect and safety profile as compared to ETT in otherwise healthy children with gastrointestinal complaints
Study design The study will be randomized, controlled, and prospective in design.
Comparison groups The two comparison groups will be:
Study and timeline of interventions
i. Time from induction of anesthesia to placement of the airway device ii. Time from end of procedure to arrival in the PACU iii. Time spent in the PACU iv. Overall time from arrival in the OR to discharge home v. Vomiting after the procedure vi. Nausea requiring medicine after the procedure vii. Lowest oxygen saturation level during or after the procedure viii. Highest concentration of sevoflurane during the procedure ix. Highest pain level after the procedure x. Amount of pain medicine given xi. Adverse events xii. Satisfaction level of the doctor doing the EGD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Largyngeal Mask Airway for EGD procedure | Experimental | Patients randomized to LMA to maintain airway through EGD procedure |
|
| Endotracheal Tube for EGD procedure | Active Comparator | Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMA | Device | Patients randomized to the LMA group had their airways maintained with a LMA device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopist Satisfaction | Endoscopist was surveyed to determine their satisfaction with each of the airway devices. Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:
| 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| OR to Discharge (Min) | Overall time from arrival in the OR to discharge home (in minutes) | OR to discharge |
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Inclusion Criteria:• Age 3-17
Exclusion Criteria:
• Abnormal/difficult airway
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| Name | Affiliation | Role |
|---|---|---|
| Micahel Acquaviva, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24637966 | Derived | Acquaviva MA, Horn ND, Gupta SK. Endotracheal intubation versus laryngeal mask airway for esophagogastroduodenoscopy in children. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):54-6. doi: 10.1097/MPG.0000000000000348. |
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Patients were pre-screened for allergies to medications used and BMI's outside the 90th percentile. All other patients were eligible for enrollment.
Patients were recruited on the day of their scheduled endoscopic procedure in the outpatient clinic of a large children's hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | LMA Used to Maintain Airway | Patients randomized to LMA to maintain airway through EGD procedure |
| FG001 | ETT Used to Maintain Airway | Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LMA Used to Maintain Airway | Patients randomized to LMA to maintain airway through EGD procedure |
| BG001 | ETT Used to Maintain Airway | Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital |
| 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 | Endoscopist Satisfaction | Endoscopist was surveyed to determine their satisfaction with each of the airway devices. Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:
| Posted | Median | Standard Deviation | units on a scale | 2 hours |
|
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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 | LMA Used to Maintain Airway | Patients randomized to LMA to maintain airway through EGD procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| laryngospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Horn, MD | IndianaU | 3179449981 | ndhorn@hotmail.com |
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| ETT | Device | Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital |
|
| 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 |
|
| Endotracheal Tube for EGD Procedure |
Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital |
|
|
| Secondary | OR to Discharge (Min) | Overall time from arrival in the OR to discharge home (in minutes) | Posted | Mean | Standard Deviation | Minutes | OR to discharge |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | ETT Used to Maintain Airway | Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital | 0 | 42 | 3 | 42 |
| asthma exacerbation postop | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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