Combined LMA + ETT Technique for Emergence Phenomena
(LEPAGA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting emergence phenomena such as coughing, straining, restlessness, and sympathetic stimulation leading to hypertension and tachycardia.Many anesthesiologists would prefer the use of an ETT to an LMA in cases in which higher ventilation pressures may be required, in those patients who are perceived to be high risk for reflux and pulmonary aspiration of gastric contents, as well as during cases that allow the anesthesiologist to have little accessibility the airway.The aim of this study is to investigate an airway management technique that would allow for the benefits of the ETT in terms of a secure airway for the duration of the surgical procedure as well the potential for less emergence phenomena seen when emerging with an LMA.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the combined LMA + ETT technique generally safe for use in humans?
How does the Combined LMA + ETT Technique for Emergence Phenomena differ from other treatments?
The Combined LMA + ETT Technique is unique because it uses both a laryngeal mask airway (LMA) and an endotracheal tube (ETT) to manage the airway, aiming to reduce coughing and hemodynamic changes (blood pressure and heart rate fluctuations) during emergence from anesthesia. This approach combines the benefits of both devices, potentially offering a smoother recovery compared to using an ETT alone.46789
What data supports the effectiveness of this treatment for emergence phenomena?
Research shows that using a laryngeal mask airway (LMA) can be safer and more effective than an endotracheal tube (ETT) in certain surgeries, as it reduces coughing and other changes during extubation (removal of the breathing tube). Additionally, LMA insertion is often quicker and more successful on the first attempt compared to ETT.4691011
Who Is on the Research Team?
Arne Budde, MD
Principal Investigator
Penn State M.S. Hershey Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction and Airway Management
Induction of anesthesia and initial airway management with LMA, followed by intubation with ETT using a fiberoptic bronchoscope.
Surgical Procedure
Ventilation with ETT throughout the surgical procedure.
Emergence
Removal of ETT while deeply anesthetized, followed by ventilation with LMA until emergence.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of sore throat and oropharyngeal sensory or motor nerve palsy.
What Are the Treatments Tested in This Trial?
Interventions
- Emergence from anesthesia
- Induction of anesthesia
- Intubation of the trachea through the LMA
- Laryngoscopy and placement of ETT
- Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]
- Removal of the ETT
- Ventilation via the ETT
- Ventilation via the LMA
Laryngoscopy and placement of ETT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
Ambu A/S
Industry Sponsor