Laryngeal Mask Airway in Laparoscopic Hernia Repair

Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair

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.

Study Overview

• Status: Recruiting
• Conditions: Inguinal Hernia; Inguinal Hernia, Indirect; Inguinal Hernia Unilateral; Inguinal Hernia Bilateral
• Intervention / Treatment: Device: Laryngeal Mask Airway; Device: Endotracheal Tube Device

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emily Weisberg, MD; Phone Number: 8164584006; Email: eweisberg@cmh.edu
• Study Contact Backup: Name: Tolulope Oyetunji, MD; Phone Number: 8162343575; Email: taoyetunji@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Recruiting
      • Children's Mercy Hospital
      • Contact: Emily Weisberg, MD; Phone Number: 816-458-4006; Email: eweisberg@cmh.edu
      • Contact: Tolulope Oyetunji, MD; Phone Number: (816) 234-3575; Email: taoyetunji@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): September 27, 2024
• Study Completion (Estimated): September 27, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Study00002580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No