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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

Must not have

Individuals who cannot provide consent

Patients with anticipated difficult airway requiring maintenance of spontaneous ventilation (awake intubation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 week

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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My health is good to moderately impaired.

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I am scheduled for elective laparoscopic surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to give consent by myself.

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I need a special procedure for anesthesia because my airway is difficult to manage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in rate pressure product during emergence

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met