Laryngeal Mask Airway in Laparoscopic Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06023394
• Other study ID #: Study00002580
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: September 27, 2024

Study information

• Verified date: April 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: Emily Weisberg, MD
• Phone: 8164584006
• Email: eweisberg[@]cmh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Inguinal Hernia Bilateral
• Inguinal Hernia Unilateral
• Inguinal Hernia, Indirect

Intervention

Device:
• Laryngeal Mask Airway
Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
• Endotracheal Tube Device
Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patients will have oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Secondary	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.	Patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Secondary	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.	Patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Secondary	Documentation of laryngospasm occurrence	Will document if laryngospasm occurs in both groups at any time during the surgery.	Patients will have the occurrence of laryngospasm documented at any time point during the surgery
Secondary	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%.	Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.