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NCT Number: NCT06023394

Laryngeal Mask Airway in Laparoscopic 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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Inguinal Hernia Bilateral Inguinal Hernia Unilateral Inguinal Hernia, Indirect Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

12 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laryngeal mask airway

Device

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

Endotracheal Tube Device

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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