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This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.
This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. This study aims to add to this literature in providing information comparing the two techniques. The rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Receives Laryngeal Mask Airway Device | Other | In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. |
|
| Cohort B: Receives Endotracheal Tube Device | Other | In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Mask Airway | Device | Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic | Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| End-tidal Carbon Dioxide Measured by Capnography in mm Hg | Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia. | Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40381798 | Derived | Weisberg EL, Pieters BJ, Elman MS, Nonnemacher CJ, Noel-MacDonnell J, Oyetunji TA. The Use of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial. J Pediatr Surg. 2025 Aug;60(8):162367. doi: 10.1016/j.jpedsurg.2025.162367. Epub 2025 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Receives Laryngeal Mask Airway Device | In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion. |
| FG001 | Cohort B: Receives Endotracheal Tube Device | In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Receives Laryngeal Mask Airway Device | In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion. |
| BG001 |
| 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 | Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation | Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic | Posted | Median | Inter-Quartile Range | Percent Saturation | Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. |
|
During anesthetic time, defined as induction of anesthesia, to time of LMA or ETT removal documented by the anesthesia time, assessed up to 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 | Cohort A: Receives Laryngeal Mask Airway Device | In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. Laryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Weisberg, pediatric anesthesiologist | Children's Mercy Kansas City | 9136605813 | eweisberg@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2024 | Feb 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| Endotracheal Tube Device | Device | Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. |
|
| Peak Airway Pressure Will be Measured in cm H2O | Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia. | Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. |
| Documentation of Laryngospasm Occurrence | Will document if laryngospasm occurs in both groups at any time during the surgery. | Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours. |
| Documentation of Oxygen Desaturation | Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%. | Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours. |
| Did not receive allocated intervention (Patient received ETT per surgeon) |
|
| Did not received allocated intervention (no airway device documented in EMR) |
|
| Cohort B: Receives Endotracheal Tube Device |
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. |
|
|
| Secondary | End-tidal Carbon Dioxide Measured by Capnography in mm Hg | Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia. | Posted | Median | Inter-Quartile Range | millimeters mercury (mm Hg) | Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours. |
|
|
|
| Secondary | Peak Airway Pressure Will be Measured in cm H2O | Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia. | Posted | Median | Inter-Quartile Range | cm H20 | Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours. |
|
|
|
| Secondary | Documentation of Laryngospasm Occurrence | Will document if laryngospasm occurs in both groups at any time during the surgery. | Posted | Number | Presence of laryngospasm | Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours. |
|
|
|
| Secondary | Documentation of Oxygen Desaturation | Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%. | Posted | Number | Occurence of oxygen desaturation | Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Cohort B: Receives Endotracheal Tube Device | In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. Endotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| ETCO2 prior to removal of airway device |
|
| Peak airway pressure prior to removal of airway device |
|