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Procedure

Breathing Tubes for Inguinal Hernia Repair

N/A

Recruiting

Research Sponsored by Children's Mercy Hospital Kansas City

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists Physical Status Classification ASA 1 or 2

English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will have end-tidal carbon dioxide measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.

Awards & highlights

Study Summary

This trial looks at the best breathing tube for inguinal hernia surgery, comparing two options: LMA and ETT.

Who is the study for?

This trial is for English and Spanish speakers aged 12 months to 8 years, classified as ASA 1 or 2, who are scheduled for elective laparoscopic inguinal hernia repair with proper fasting. It excludes those who are obese (95th percentile or higher), have contraindications to study medications, or suffer from gastroesophageal reflux.Check my eligibility

What is being tested?

The study compares the effectiveness of using a laryngeal mask airway (LMA) versus an endotracheal tube (ETT) during laparoscopic surgery for inguinal hernia in children at CMH. Patients will be randomly assigned to one of these two airway management techniques.See study design

What are the potential side effects?

Potential side effects may include discomfort in the throat area, difficulty swallowing, hoarseness, and possibly a sore throat after the procedure. The risk of aspiration or breathing difficulties could also differ between LMA and ETT.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good or mild systemic disease condition according to ASA.

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I speak English.

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I am between 1 and 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will have peak airway pressure measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oxygen Saturation measured by pulse oximetry in percent saturation

Secondary outcome measures

Documentation of laryngospasm occurrence

Documentation of oxygen desaturation

End-tidal carbon dioxide measured by capnography in mm Hg

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Receives Endotracheal Tube DeviceExperimental Treatment1 Intervention

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

Group II: Cohort A: Receives Laryngeal Mask Airway DeviceExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Laryngeal Mask Airway

2015

N/A

~840

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor

245 Previous Clinical Trials

935,749 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can applicants below the age of fifty-five participate in this research project?

"This medical trial is enrolling patients aged between one year and eight years old."

Answered by AI

What criteria must a potential participant meet in order to be included in this trial?

"To be eligible, individuals must possess an inguinal hernia and lie within the 12 Months to 8 year old age range. This particular clinical trial is slated to enroll 50 test subjects."

Answered by AI

Is this research endeavor currently recruiting participants?

"That is accurate. Details hosted on clinicaltrials.gov assert that this medical experiment, which was first shared on March 27th 2023, currently requires participants. The trial necessitates the recruitment of 50 individuals from 1 different research centre."

Answered by AI

How many people are participating in this research endeavor?

"Affirmative. According to information found on clinicaltrials.gov, the recruitment for this medical trial has started and is currently open. The initial posting was made on March 27th 2023 with the latest edit being done August 29th 2023. 50 individuals are required from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Laryngeal Mask Airway in Laparoscopic Hernia Repair

Emily Weisberg 2023. "Laryngeal Mask Airway in Laparoscopic Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023394.

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