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Laryngeal Mask Airway in Laparoscopic Hernia Repair

Primary Purpose

Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laryngeal Mask Airway
Endotracheal Tube Device
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inguinal Hernia

Eligibility Criteria

12 Months - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cohort A: Receives Laryngeal Mask Airway Device

Cohort B: Receives Endotracheal Tube Device

Arm Description

In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.

In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Documentation of laryngospasm occurrence
Will document if laryngospasm occurs in both groups at any time during the surgery.
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%.

Full Information

First Posted
August 4, 2023
Last Updated
August 29, 2023
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT06023394
Brief Title
Laryngeal Mask Airway in Laparoscopic Hernia Repair
Official Title
Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
March 27, 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Inguinal Hernia, Indirect, Inguinal Hernia Bilateral, Inguinal Hernia Unilateral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Receives Laryngeal Mask Airway Device
Arm Type
Other
Arm Description
In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.
Arm Title
Cohort B: Receives Endotracheal Tube Device
Arm Type
Other
Arm Description
In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.
Intervention Type
Device
Intervention Name(s)
Laryngeal Mask Airway
Intervention Description
Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.
Intervention Type
Device
Intervention Name(s)
Endotracheal Tube Device
Intervention Description
Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.
Primary Outcome Measure Information:
Title
Oxygen Saturation measured by pulse oximetry in percent saturation
Description
Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic
Time Frame
Patients will have oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Secondary Outcome Measure Information:
Title
End-tidal carbon dioxide measured by capnography in mm Hg
Description
Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.
Time Frame
Patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Title
Peak airway pressure will be measured in cm H2O
Description
Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.
Time Frame
Patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Title
Documentation of laryngospasm occurrence
Description
Will document if laryngospasm occurs in both groups at any time during the surgery.
Time Frame
Patients will have the occurrence of laryngospasm documented at any time point during the surgery
Title
Documentation of oxygen desaturation
Description
Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.
Time Frame
Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Weisberg, MD
Phone
8164584006
Email
eweisberg@cmh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tolulope Oyetunji, MD
Phone
8162343575
Email
taoyetunji@cmh.edu
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Weisberg, MD
Phone
816-458-4006
Email
eweisberg@cmh.edu
First Name & Middle Initial & Last Name & Degree
Tolulope Oyetunji, MD
Phone
(816) 234-3575
Email
taoyetunji@cmh.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Laryngeal Mask Airway in Laparoscopic Hernia Repair

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