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Procedure
Breathing Tubes for Inguinal Hernia Repair
N/A
Waitlist Available
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
Must not have
Obesity (CDC >= 95th %ile)
Contraindications to study protocol medications
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.
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am considered obese according to CDC guidelines.
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I am not allergic or unable to take the study's medications.
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I currently have acid reflux.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will have oxygen saturation 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 oxygen saturation measured directly after intubation, five minutes after the start of surgery, and immediately prior to extubation.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Oxygen Saturation measured by pulse oximetry in percent saturation
Secondary study objectives
Documentation of laryngospasm occurrence
Documentation of oxygen desaturation
End-tidal carbon dioxide measured by capnography in mm Hg
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
257 Previous Clinical Trials
940,434 Total Patients Enrolled