Laryngeal Mask Airway in Laparoscopic Hernia Repair

NCT ID: NCT06023394

Last Updated: 2025-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2024-05-08

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Laryngeal Mask Airway

Intervention Type DEVICE

Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.

Cohort B: Receives Endotracheal Tube Device

In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.

Group Type OTHER

Endotracheal Tube Device

Intervention Type DEVICE

Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.

Interventions

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Laryngeal Mask Airway

Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.

Intervention Type DEVICE

Endotracheal Tube Device

Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Mercy Hospital Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Emily Weisberg

Physican, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Countries

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United States

References

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Weisberg EL, Pieters BJ, Elman MS, Nonnemacher CJ, Noel-MacDonnell J, Oyetunji TA. The Use of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial. J Pediatr Surg. 2025 Aug;60(8):162367. doi: 10.1016/j.jpedsurg.2025.162367. Epub 2025 May 15.

Reference Type DERIVED
PMID: 40381798 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Study00002580

Identifier Type: -

Identifier Source: org_study_id

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