MedPath

Laryngeal Mask Airway in Laparoscopic Hernia Repair

Not Applicable
Completed
Conditions
Inguinal Hernia Unilateral
Inguinal Hernia, Indirect
Inguinal Hernia
Inguinal Hernia Bilateral
Interventions
Device: Laryngeal Mask Airway
Device: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Cohort A: Receives Laryngeal Mask Airway DeviceLaryngeal Mask AirwayIn this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Cohort B: Receives Endotracheal Tube DeviceEndotracheal Tube DeviceIn this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Primary Outcome Measures
NameTimeMethod
Oxygen Saturation Measured by Pulse Oximetry in Percent SaturationPatients 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
NameTimeMethod
End-tidal Carbon Dioxide Measured by Capnography in mm HgPatients 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 H2OPatients 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 OccurrencePatients 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 DesaturationPatients 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

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