Laryngeal Mask Airway in Laparoscopic Hernia Repair
- Conditions
- Inguinal Hernia UnilateralInguinal Hernia, IndirectInguinal HerniaInguinal Hernia Bilateral
- Interventions
- Device: Laryngeal Mask AirwayDevice: Endotracheal Tube Device
- Registration Number
- NCT06023394
- Lead Sponsor
- Children's Mercy Hospital Kansas City
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- Patients with current gastroesophageal reflux
- Obesity (CDC >= 95th %ile)
- Contraindications to study protocol medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Receives Laryngeal Mask Airway Device Laryngeal Mask Airway In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device. Cohort B: Receives Endotracheal Tube Device Endotracheal Tube Device In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
- Primary Outcome Measures
Name Time Method Oxygen Saturation Measured by Pulse Oximetry in 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. Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
- Secondary Outcome Measures
Name Time Method End-tidal Carbon Dioxide Measured by Capnography in 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. 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 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. 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, assessed up to 2 hours. 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, assessed up to 2 hours. Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
Trial Locations
- Locations (1)
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States