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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06023394
Other study ID # Study00002580
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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