Laryngeal Mask Airway in Laparoscopic Hernia Repair
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Device: Laryngeal Mask Airway
Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
|
| Other: Cohort B: Receives Endotracheal Tube Device In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device. |
Device: Endotracheal Tube Device
Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
|
Outcome Measures
Primary Outcome Measures
- Oxygen Saturation measured by pulse oximetry in percent saturation [Patients will have oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.]
Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
Secondary Outcome Measures
- End-tidal carbon dioxide measured by capnography in mm Hg [Patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.]
Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.
- Peak airway pressure will be measured in cm H2O [Patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.]
Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.
- Documentation of laryngospasm occurrence [Patients will have the occurrence of laryngospasm documented at any time point during the surgery]
Will document if laryngospasm occurs in both groups at any time during the surgery.
- Documentation of oxygen desaturation [Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.]
Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients undergoing laparoscopic inguinal hernia repair.
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Ages 12 months to 8 years of age
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American Society of Anesthesiologists Physical Status Classification ASA 1 or 2
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ASA 1- A normal, healthy patient
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ASA 2- A patient with mild systemic disease
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Elective with appropriate NPO status
-
English speakers
-
Spanish speakers
Exclusion Criteria:
-
Patients with current gastroesophageal reflux
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Obesity (CDC >= 95th %ile)
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Contraindications to study protocol medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Mercy Hospital | Kansas City | Missouri | United States | 64108 |
Sponsors and Collaborators
- Children's Mercy Hospital Kansas City
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Study00002580