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.
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
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Weisberg, Children's Mercy Hospital Kansas City
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