Combined LMA + ETT Technique for Emergence Phenomena
(LEPAGA Trial)
Recruiting in Palo Alto (17 mi)
Overseen byArne Budde, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Milton S. Hershey Medical Center
Disqualifiers: Non-consent, Prisoners, Parturients, others
No Placebo Group
Trial Summary
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.
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.
12345Is the combined LMA + ETT technique generally safe for use in humans?
Research indicates that the Ambu AuraGain laryngeal mask, used in combination with an endotracheal tube, is generally safe for airway management in both adults and children, with minor complications like sore throat and voice changes being similar to other devices.
16789How 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.
1231011Eligibility Criteria
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
My health is good to moderately impaired.
I am scheduled for elective laparoscopic surgery.
Exclusion Criteria
Parturients
Non-fasted patients (as per HMC Anesthesiology Department NPO policy)
Patients felt to be high risk for gastric reflux and pulmonary aspiration (those with gastroparesis, symptomatic GERD, etc. at the discretion of primary anesthesia team)
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Induction and Airway Management
Induction of anesthesia and initial airway management with LMA, followed by intubation with ETT using a fiberoptic bronchoscope.
Intraoperative
Surgical Procedure
Ventilation with ETT throughout the surgical procedure.
Intraoperative
Emergence
Removal of ETT while deeply anesthetized, followed by ventilation with LMA until emergence.
Intraoperative
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of sore throat and oropharyngeal sensory or motor nerve palsy.
Up to 1 week
Participant Groups
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.
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.
Laryngoscopy and placement of ETT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
🇺🇸 Approved in United States as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
- Emergency airway management
🇨🇦 Approved in Canada as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
🇯🇵 Approved in Japan as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
🇨🇳 Approved in China as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
🇨🇭 Approved in Switzerland as Endotracheal Tube for:
- General anesthesia for surgical procedures
- Mechanical ventilation
- Airway management in critical care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Penn State Health - Hershey Medical CenterHershey, PA
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Who Is Running the Clinical Trial?
Milton S. Hershey Medical CenterLead Sponsor
Ambu A/SIndustry Sponsor
References
Laryngeal mask airway use in otologic surgery. [2009]The purpose of this study was to evaluate the safety and efficacy of the laryngeal mask airway (LMA) compared with oral endotracheal tube (ETT) in general anesthesia in patients who underwent otologic surgery.
Comparison of classic laryngeal mask airway with Ambu laryngeal mask for tracheal tube exchange: A prospective randomized controlled study. [2021]Exchanging endotracheal tube (ETT) with classic laryngeal mask airway™ (CLMA™) prior to emergence from anaesthesia is a safe technique to prevent the coughing and haemodynamic changes during extubation. We had compared CLMA™ and AMBU laryngeal mask™ (ALM™) during ETT/laryngeal mask (LM) for haemodynamic changes and other parameters.
Laryngeal mask versus endotracheal tube for airway management in tracheal surgery: a case-control matching analysis and review of the current literature. [2022]The endotracheal tube (ETT) and the laryngeal mask airway (LMA) are possible strategies for airway management during tracheal resection and reconstruction for tracheal and laryngotracheal stenosis. The goal of the study was to analyse and compare outcomes in the LMA and ETT groups.
Sparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA Supreme and the ETT. [2022]We designed a prospective randomized single-blind study to compare efficiency and post-operative upper airway morbidity when the laryngeal mask airway (LMA) Supreme is used as an alternative to the endotracheal tube (ETT).
Laryngeal mask airway and tracheal tube insertion by unskilled personnel. [2022]After a short training programme 11 naval medical trainees inserted a laryngeal mask airway (LMA) and a tracheal tube (ETT) in random order in a total of 110 anaesthetised patients. They were allowed 40 s for each attempt. Success was defined as the detection of expired carbon dioxide within 40 s of Guedel airway removal which subsequently rose to an end-tidal value of at least 4 kPa, together with satisfactory lung expansion and ventilation, without other airway intervention by the anaesthetist. 104 LMA insertions were successful compared with 56 of ETTs (p less than 0.01). All first attempts at LMA insertion were successful, whereas satisfactory ETT placement was progressive. Insertion was also quicker with the LMA (20 s) than with the ETT (35 s) (p less than 0.01). Further studies are indicated to assess the value of the LMA in emergencies.
Flexible bronchoscopic intubation through the AuraGain™ laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. [2018]Label="PURPOSE" NlmCategory="OBJECTIVE">AuraGainTM, a novel third-generation laryngeal mask, can facilitate insertion of a gastric tube and provide the potential advantage of intubation. Data are lacking on intubation through the AuraGain laryngeal mask.
A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu® AuraGain™ laryngeal mask and LMA® Fastrach™. [2022]The Ambu®AuraGain™ laryngeal mask (LM) (Ambu A/S, Ballerup, Denmark) is one of the few readily available second-generation supraglottic airway devices (SADs) that offer a conduit for fibreoptic-guided endotracheal intubation. We aimed to compare fibreoptic intubation through this device with the LMA® (laryngeal mask airway) Fastrach™ (Teleflex Medical, Co. Westmeath, Ireland), which has been a recommended dedicated rescue device for the management of the unanticipated difficult airway. This randomised controlled trial compared a previously described fibreoptic score in 116 patients with no known airway pathology, who had asleep fibreoptic endotracheal intubation via either the AuraGain LM or the LMA Fastrach. Time, ease and success rate of SAD and endotracheal tube (ETT) insertion and complications were recorded. The AuraGain LM demonstrated better laryngeal alignment with 29 out of 59 patients in the AuraGain LM (AG) group having a Grade 4 view (only vocal cords visible), compared to 20 out of 54 patients in the LMA Fastrach (FT) group (P=0.003). It allowed significantly quicker and easier ETT intubation when used as a conduit. The AuraGain LM was also quicker to insert compared to the Fastrach LMA. Similar rates of minor complications, such as sore throat and dysphonia occurred in both groups. Our study indicates that when used in patients with complete muscle relaxation and no known airway pathology, the AuraGain LM achieves better laryngeal alignment and quicker, easier and more successful fibreoptic-guided ETT intubation than the Fastrach LMA.
A randomised comparison of the Ambu® AuraGain™ and the LMA® supreme in infants and children. [2022]We conducted a randomised trial in 100 children in order to compare the clinical performance of the Ambu(®) AuraGain(™) and the LMA(®) Supreme(*) for airway maintenance during mechanical ventilation. The primary outcomes were initial and 10-min airway leak pressures. Ease, time and success rates for device and gastric tube insertion, fibreoptic grades of view, airway quality during anaesthetic maintenance, and complications were also assessed. There were no differences in the initial and ten min airway leak pressures between the Ambu AuraGain and LMA Supreme, median (IQR [range]) initial: 19 (16-22 [10-34]) vs 18 (14-24 [8-40]) cmH2 O, p = 0.4; and ten min: 22 (18-26 [11-40]) vs 20 (16-26 [12-40]) cmH2 O, p = 0.08, respectively. Ease, time and success rates for device placement, gastric tube insertion and complications were also not significantly different. Children receiving the LMA Supreme required more airway manouevers (7 vs 1 patient, p = 0.06) to maintain a patent airway. Our results suggest that the Ambu AuraGain may be a useful alternative to the LMA Supreme, as demonstrated by comparable overall clinical performance in children.
Are the King LTS Laryngeal Tube and the Ambu AuraOnce Laryngeal Mask Useful Airway Adjuncts for Military Medics? [2022]Airway management is a critical skill that may be essential in the battlefield. The aim of this study was to determine if combat life savers and medics with no or limited clinical experience could provide airway control using the disposable laryngeal suction tube (LTS-D) and the Ambu® AuraOnce ™ disposable laryngeal mask (LMA).
Use of laryngeal mask airway in pediatric adenotonsillectomy. [2022]To compare the use of flexible laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy.
Laryngeal mask airways in ear, nose, and throat procedures. [2010]The use of laryngeal mask airway (LMA) and its variants in ear, nose, and throat procedures have been extensively described in case reports, retrospective reviews, and randomized clinical trials. The LMA has developed a considerable following because of its lack of tracheal stimulation, which can be a considerable advantage in ear, nose, and throat (ENT) procedures. The incidence of coughing on emergence has been shown to be lower with the LMA than with the endotracheal tube (ETT). Although other approaches to smooth emergence have been described, few would argue that it is as easy to achieve a smooth emergence with an ETT as with an LMA. Although patients certainly exist for whom the LMA is contraindicated, many will experience better results with the LMA because of the features delineated in this article.