Clinical trial NCT06023394: Laryngeal Mask Airway in Laparoscopic Hernia Repair
Official title: Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Inguinal Hernia, Indirect
Inguinal Hernia Bilateral
Inguinal Hernia Unilateral
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation
timeFrame: 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:
measure: End-tidal Carbon Dioxide Measured by Capnography in mm Hg
timeFrame: 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.
measure: Peak Airway Pressure Will be Measured in cm H2O
timeFrame: 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.
measure: Documentation of Laryngospasm Occurrence
timeFrame: Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.
measure: Documentation of Oxygen Desaturation
timeFrame: Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
References: