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Laryngeal Mask Airway in Laparoscopic Hernia Repair

Children's Mercy Hospital Kansas City logo

Children's Mercy Hospital Kansas City

Status

Completed

Conditions

Inguinal Hernia Bilateral
Inguinal Hernia Unilateral
Inguinal Hernia
Inguinal Hernia, Indirect

Treatments

Device: Laryngeal Mask Airway
Device: Endotracheal Tube Device

Study type

Interventional

Funder types

Other

Identifiers

NCT06023394
Study00002580

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

12 months to 8 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

62 participants in 2 patient groups

Cohort A: Receives Laryngeal Mask Airway Device
Other group
Description:
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Treatment:
Device: Laryngeal Mask Airway
Cohort B: Receives Endotracheal Tube Device
Other group
Description:
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Treatment:
Device: Endotracheal Tube Device

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Tolulope Oyetunji, MD; Emily Weisberg, MD

Data sourced from clinicaltrials.gov

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