Inguinal HerniaNCT06023394

Laryngeal Mask Airway in Laparoscopic Hernia Repair

A study testing Laryngeal Mask Airway and Endotracheal Tube Device in people with Inguinal Hernia and Inguinal Hernia, Indirect, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 months to 8 years
Conditions the study is for: Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral
What is being tested?: Laryngeal Mask Airway and Endotracheal Tube Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2023to 8 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Hospital
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Being tested: Laryngeal Mask Airway, Endotracheal Tube Device
Medical subject headings: Hernia, Inguinal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Laryngeal Mask AirwayDevice
Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
Endotracheal Tube DeviceDevice
Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.

Study groups in NCT06023394
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Endotracheal Tube Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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 by capnography in mm Hg at three standardized time points during anesthesia.
Measured: 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 in cm H2O measured at three standardized time points during anesthesia.
Measured: 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
Will document if laryngospasm occurs in both groups at any time during the surgery.
Measured: Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.
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%.
Measured: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20238 May 2024

First posted5 Sep 2023
Study start27 Mar 2023
Primary completion8 May 2024
Study completion8 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Inguinal HerniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06023394
Sponsor's protocol ID: Study00002580
Status last verified: Apr 2025
First submitted: 4 Aug 2023
Last updated: 3 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 40381798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Inguinal Hernia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair
ClinicalTrials.gov ID: NCT06023394
Acronym / sponsor ID: Study00002580
Conditions: Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Study start: 27 Mar 2023 (actual)
Primary completion: 8 May 2024 (actual)
Study completion: 8 May 2024 (actual)
First posted: 5 Sep 2023 (actual)
Results: Posted 3 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

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

Who may qualify

Ages: 12 months to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laryngeal Mask AirwayLaryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.	Device	Cohort A: Receives Laryngeal Mask Airway Device
Endotracheal Tube DeviceEndotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.	Device	Cohort B: Receives Endotracheal Tube Device

Primary outcome

Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
Time frame: 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

4 secondary outcomes

End-tidal Carbon Dioxide Measured by Capnography in mm Hg
Time frame: 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
Time frame: 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
Time frame: Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.
Documentation of Oxygen Desaturation
Time frame: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.

Results and safety

Results posted to the registry on 3 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A: Receives Laryngeal Mask Airway Device	31	25
Cohort B: Receives Endotracheal Tube Device	31	25

Primary outcome: Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation

Time frame: 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.. Median (Inter-Quartile Range). Unit: Percent Saturation

Measure	Cohort A: Receives Laryngeal Mask Airway Device n = 25	Cohort B: Receives Endotracheal Tube Device n = 25
SpO2 after placement airway device	100 (100 to 100)	100 (99 to 100)
SpO2 5 minutes after surgery start	100 (100 to 100)	100 (99 to 100)
SpO2 prior to airway device removal	100 (100 to 100)	100 (99 to 100)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During anesthetic time, defined as induction of anesthesia, to time of LMA or ETT removal documented by the anesthesia time, assessed up to 2 hours.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A: Receives Laryngeal Mask Airway Device	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Cohort B: Receives Endotracheal Tube Device	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40381798Weisberg 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.
Individual participant dataSharing planned: No

Related trials for Inguinal Hernia

Recruiting
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Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
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Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06023394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.