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Combined LMA + ETT Technique for Emergence Phenomena (LEPAGA Trial)
N/A
Recruiting
Led By Justin Pachuski, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ASA 1-3
Patients undergoing elective laparoscopic surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 week
Awards & highlights
LEPAGA Trial Summary
This trial is testing whether using a laryngeal mask airway during surgery and then switching to an endotracheal tube for emergence from anesthesia results in fewer complications than using an endotracheal tube the entire time.
Who is the study for?
This trial is for adults with an ASA classification of 1-3 who are having elective laparoscopic surgery. It's not for those unable to consent, needing translators for consent, prisoners, pregnant women, non-fasted patients or at high risk of gastric reflux and aspiration.Check my eligibility
What is being tested?
The study tests a technique combining laryngeal mask airway (LMA) and endotracheal tube (ETT) to see if it can provide a secure airway during surgery while reducing emergence phenomena like coughing and restlessness after anesthesia.See study design
What are the potential side effects?
Potential side effects may include discomfort from the LMA or ETT placement, sore throat, difficulty swallowing, hoarseness, nausea related to anesthesia emergence phenomena such as coughing or straining.
LEPAGA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderately impaired.
Select...
I am scheduled for elective laparoscopic surgery.
LEPAGA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in rate pressure product during emergence
Secondary outcome measures
Change in rate pressure product during induction of anesthesia and intubation
LMA cuff pressures prior to removal of ETT.
LMA cuff pressures when inflated to seal
+7 moreLEPAGA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Combined ETT/LMA techniqueExperimental Treatment7 Interventions
Placement of LMA after induction of anesthesia. Intubation of trachea with ETT via LMA with fiberoptic bronchoscope. Ventilation with ETT throughout case. Removal of ETT while deeply anesthetized. Ventilation with LMA until emergence.
Group II: ETT onlyActive Control5 Interventions
Endotracheal tube intubation after induction of anesthesia. Ventilation with ETT until emergence.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,878 Total Patients Enrolled
Ambu A/SIndustry Sponsor
22 Previous Clinical Trials
5,499 Total Patients Enrolled
Justin Pachuski, MDPrincipal InvestigatorPenn State M.S. Hershey Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollments still open for this experiment?
"According to the information hosted by clinicaltrials.gov, this trial is not currently enrolling participants - it was first made available on January 1st 2020 and has had its last update on June 20th 2022. Nevertheless, there are other studies accepting patients right now."
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