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Clinical Trials/NCT06023394
NCT06023394
Completed
Not Applicable

Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair

Children's Mercy Hospital Kansas City1 site in 1 country50 target enrollmentMarch 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
50
Locations
1
Primary Endpoint
Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 27, 2023
End Date
May 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Emily Weisberg

Physican, M.D.

Children's Mercy Hospital Kansas City

Eligibility Criteria

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

Outcomes

Primary Outcomes

Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation

Time Frame: 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 Outcomes

  • 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.)
  • 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.)
  • Documentation of Laryngospasm Occurrence(Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.)
  • 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.)

Study Sites (1)

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