Laryngeal Mask Airway in Laparoscopic Hernia Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair

Conditions
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Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral, Inguinal Hernia Unilateral

Intervention / Treatment
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* Device: Laryngeal Mask Airway
* Device: Endotracheal Tube Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic inguinal hernia repair. Ages 12 months to 8 years of age American Society of Anesthesiologists Physical Status Classification ASA 1 or 2 ASA 1- A normal, healthy patient ASA 2- A patient with mild systemic disease Elective with appropriate NPO status English speakers Spanish speakers Exclusion Criteria: Patients with current gastroesophageal reflux Obesity (CDC >= 95th %ile) Contraindications to study protocol medications

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort A: Receives Laryngeal Mask Airway Device<br>In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. | Device: Laryngeal Mask Airway<br>* Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.<br>|
| Other: Cohort B: Receives Endotracheal Tube Device<br>In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. | Device: Endotracheal Tube Device<br>* Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 intubation, five minutes after the start of surgery, and immediately prior to extubation. | 

Secondary Outcome Measures

| Outcome Measure | 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 intubation, five minutes after the start of surgery, and immediately prior to extubation. | 
| 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 intubation, five minutes after the start of surgery, and immediately prior to extubation. | 
| 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 | 
| 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. |