Laryngeal Mask Airway in Laparoscopic Hernia Repair

NCT06023394 | Completed Results FDA Device

• 1 other identifier: Study00002580
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 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.

Secondary Outcomes (4)

• 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 Arms (2)

Cohort A: Receives Laryngeal Mask Airway Device

OTHER

In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.

Device: Laryngeal Mask Airway

Cohort B: Receives Endotracheal Tube Device

OTHER

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

Device: Endotracheal Tube Device

Interventions

Laryngeal Mask Airway DEVICE

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

Cohort A: Receives Laryngeal Mask Airway Device

Endotracheal Tube Device DEVICE

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

Cohort B: Receives Endotracheal Tube Device

Eligibility Criteria

• Age: 12 Months - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients with current gastroesophageal reflux
• Obesity (CDC \>= 95th %ile)
• Contraindications to study protocol medications

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• 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.

  PMID: 40381798 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Emily Weisberg, pediatric anesthesiologist
• Organization: Children's Mercy Kansas City

eweisberg@cmh.edu

9136605813

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physican, M.D.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 5, 2023
• Study Start: March 27, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: April 3, 2025
• Results First Posted: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)