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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 weeks
Treatment ~ Varies
Follow Up ~patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery. 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

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Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
248 Previous Clinical Trials
935,909 Total Patients Enrolled
~8 spots leftby Sep 2024
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