NCT06023394

Laryngeal Mask Airway in Laparoscopic Hernia Repair

Completed NA Results posted Last updated 3 April 2025

What this trial tests

NA trial testing Laryngeal Mask Airway in Inguinal Hernia in 62 participants. Completed in 8 May 2024.

Timeline

27 March 2023

Primary endpoint
8 May 2024

8 May 2024

Quick facts

Lead sponsor	Children's Mercy Hospital Kansas City
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	62
Start date	27 March 2023
Primary completion	8 May 2024
Estimated completion	8 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Laryngeal Mask Airway
• Endotracheal Tube Device

Conditions studied

• Inguinal Hernia — all drugs for Inguinal Hernia →
• Inguinal Hernia, Indirect — all drugs for Inguinal Hernia, Indirect →
• Inguinal Hernia Bilateral — all drugs for Inguinal Hernia Bilateral →
• Inguinal Hernia Unilateral — all drugs for Inguinal Hernia Unilateral →

Sponsor

Children's Mercy Hospital Kansas City

Who can join

Adults 12 Months to 8, any sex, with Inguinal Hernia or Inguinal Hernia, Indirect. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation Primary · 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

SpO2 after placement airway device

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	100	100 – 100
Cohort B: Receives Endotracheal Tube Device	100	99 – 100

SpO2 5 minutes after surgery start

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	100	100 – 100
Cohort B: Receives Endotracheal Tube Device	100	99 – 100

SpO2 prior to airway device removal

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	100	100 – 100
Cohort B: Receives Endotracheal Tube Device	100	99 – 100

End-tidal Carbon Dioxide Measured by Capnography in mm Hg Secondary · 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.

Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.

ETCO2 after placement of airway device

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	44	39 – 50
Cohort B: Receives Endotracheal Tube Device	43	41 – 48

ETCO2 5 minutes after surgery start

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	47	43 – 49
Cohort B: Receives Endotracheal Tube Device	48	42 – 50

ETCO2 prior to removal of airway device

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	45	43 – 53
Cohort B: Receives Endotracheal Tube Device	49	43 – 57

Peak Airway Pressure Will be Measured in cm H2O Secondary · 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.

Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.

Peak airway pressure after placement of airway device

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	11	7 – 12
Cohort B: Receives Endotracheal Tube Device	14	12 – 16

Peak airway pressure 5 minutes after surgery start

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	13	11 – 14
Cohort B: Receives Endotracheal Tube Device	16	15 – 19

Peak airway pressure prior to removal of airway device

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	7	1 – 11
Cohort B: Receives Endotracheal Tube Device	11	5 – 14

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

Will document if laryngospasm occurs in both groups at any time during the surgery.

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	0
Cohort B: Receives Endotracheal Tube Device	0

Documentation of Oxygen Desaturation Secondary · Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.

Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.

Group	Value	95% CI
Cohort A: Receives Laryngeal Mask Airway Device	1
Cohort B: Receives Endotracheal Tube Device	1

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Use of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial.
   Weisberg EL, Pieters BJ, Elman MS, Nonnemacher CJ, et al · · 2025 · cited 1× · PMID 40381798 · DOI 10.1016/j.jpedsurg.2025.162367