Combined LMA + ETT Technique for Emergence Phenomena

(LEPAGA Trial)

Overseen By Arne Budde, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Non-consent, Prisoners, Parturients, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people wake up more comfortably after surgery. Researchers compare two anesthesia techniques: one using an endotracheal tube (ETT) and another combining an ETT with a laryngeal mask airway (LMA). The goal is to determine if this combined method can reduce issues like coughing or restlessness upon waking. It suits those undergoing elective laparoscopic surgery without a high risk of stomach acid reflux. As an unphased trial, this study allows participants to contribute to innovative research that could enhance post-surgical recovery experiences.

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 prior data suggests that this airway management technique is safe?

Research shows that using an Ambu AuraGain laryngeal mask airway (LMA) with an endotracheal tube (ETT) is generally safe for assisting adult breathing during surgery. This method can reduce issues like coughing, straining, and restlessness upon waking from anesthesia, which can otherwise cause high blood pressure and a rapid heartbeat.

Other studies using similar device combinations have also proven safe and helped maintain stable heart rate and blood pressure during surgery. This suggests that patients generally tolerate this combined approach well. However, since this trial specifically examines this combination further, participants should know it might not provide complete information on long-term safety. Still, current research offers a reassuring view of the treatment's safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined LMA and ETT technique for managing emergence phenomena because it offers a novel approach to airway management. Unlike the traditional method of endotracheal tube (ETT) intubation, this technique involves placing a laryngeal mask airway (LMA) first, followed by ETT intubation through the LMA with a fiberoptic bronchoscope. This method aims to reduce airway trauma and improve patient comfort during anesthesia emergence by allowing the ETT to be removed while the patient is still deeply anesthetized, with ventilation continuing via the LMA until full emergence. This innovative approach could lead to smoother recoveries and fewer complications compared to standard ETT-only procedures.

What evidence suggests that this trial's airway management techniques could be effective for reducing emergence phenomena?

Research has shown that using a laryngeal mask airway (LMA) during recovery from general anesthesia can reduce issues such as coughing, restlessness, and high blood pressure. This trial will compare two approaches: one group will use only an endotracheal tube (ETT), while another group will use a combined LMA and ETT technique. The combined technique aims to offer the benefits of both methods, maintaining a secure airway like the ETT during surgery while reducing waking-up issues like the LMA. Studies suggest this combination can lead to more stable conditions as patients wake up. This approach may be particularly beneficial in surgeries requiring higher breathing support or for patients at risk of stomach acid reflux. ^{1 2 4 5 6}

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

I am scheduled for elective laparoscopic surgery.

My health is good to moderately impaired.

Exclusion Criteria

Parturients

Non-fasted patients (as per HMC Anesthesiology Department NPO policy)

Individuals who would require translation services to provide consent

Timeline for a Trial Participant

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

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Combined ETT/LMA technique Experimental Treatment 7 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 only Active Control 5 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

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Ambu A/S

Industry Sponsor

Trials

24

Recruited

5,700+

Published Research Related to This Trial

In a study of 116 patients, the Ambu®AuraGain™ laryngeal mask (LM) provided better laryngeal alignment for fibreoptic intubation compared to the LMA® Fastrach™, with 49% of patients achieving a Grade 4 view versus 37% for the Fastrach (P=0.003).

The AuraGain LM also allowed for significantly quicker and easier endotracheal tube (ETT) intubation and was faster to insert than the Fastrach LMA, while both devices had similar rates of minor complications like sore throat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial comparing fibreoptic-guided tracheal intubation through two supraglottic devices: Ambu® AuraGain™ laryngeal mask and LMA® Fastrach™. Preece, G., Ng, I., Lee, K., et al.[2022]

In a study of 484 patients undergoing otologic surgery, the laryngeal mask airway (LMA) was found to be a safe alternative to the oral endotracheal tube (ETT), with no major airway complications reported in either group.

The LMA group required significantly fewer neuromuscular blocking agents and had shorter operating room times compared to the ETT group, indicating potential benefits in efficiency without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal mask airway use in otologic surgery. Ayala, MA., Sanderson, A., Marks, R., et al.[2009]

In a study involving eight military medics with limited clinical experience, the Ambu® AuraOnce ™ disposable laryngeal mask (LMA) achieved a 100% success rate for airway management on the first attempt, indicating it is highly effective and requires minimal training for use.

The disposable laryngeal suction tube (LTS-D) had a first-attempt success rate of 73.7% overall, but the LMA significantly reduced the time to verified ventilation, suggesting that the LMA is the preferred airway adjunct for inexperienced providers in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are the King LTS Laryngeal Tube and the Ambu AuraOnce Laryngeal Mask Useful Airway Adjuncts for Military Medics? Regner, D., Frykholm, P.[2022]

In a randomized trial involving 100 children, the Ambu AuraGain and LMA Supreme showed no significant differences in airway leak pressures during mechanical ventilation, indicating comparable efficacy in maintaining airway integrity.

The Ambu AuraGain may be a preferable option as it required fewer airway maneuvers compared to the LMA Supreme, suggesting it could be easier to use in clinical practice for airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised comparison of the Ambu® AuraGain™ and the LMA® supreme in infants and children. Jagannathan, N., Hajduk, J., Sohn, L., et al.[2022]

In a study involving 11 naval medical trainees and 110 anaesthetized patients, the laryngeal mask airway (LMA) was significantly more successful in insertion compared to the endotracheal tube (ETT), with 104 successful LMA insertions versus 56 successful ETT insertions (p < 0.01).

The LMA was not only more successful on the first attempt but also quicker to insert, taking an average of 20 seconds compared to 35 seconds for the ETT (p < 0.01), suggesting it may be a more efficient option for airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal mask airway and tracheal tube insertion by unskilled personnel. Davies, PR., Tighe, SQ., Greenslade, GL., et al.[2022]

In a study involving 131 children aged 2-12 undergoing adenotonsillectomy, the use of a flexible laryngeal mask airway (LMA) was found to be an effective alternative to the endotracheal tube (ETT), with similar rates of postoperative laryngospasm (12.5% for LMA vs. 9.6% for ETT).

Patients using the LMA experienced a significantly shorter time to extubation by about 4 minutes compared to those using the ETT, although some issues with tube kinking and visualization were noted that require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of laryngeal mask airway in pediatric adenotonsillectomy. Peng, A., Dodson, KM., Thacker, LR., et al.[2022]

The laryngeal mask airway (LMA) is preferred in ear, nose, and throat (ENT) procedures due to its ability to minimize tracheal stimulation, leading to a smoother emergence from anesthesia compared to endotracheal tubes (ETT).

Patients using the LMA experience a lower incidence of coughing upon waking, making it a more comfortable option for many, although there are specific cases where the LMA may not be suitable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal mask airways in ear, nose, and throat procedures. Mandel, JE.[2010]

In a study involving 88 patients undergoing hip or knee surgery, the AuraGain laryngeal mask demonstrated non-inferiority in intubation time compared to the standard slit Guedel tube, with mean times of 21.4 seconds versus 23.6 seconds, respectively.

The use of the AuraGain laryngeal mask resulted in successful intubation in over 95% of cases without increasing postoperative complications or discomfort, indicating it is a safe and effective alternative for intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible bronchoscopic intubation through the AuraGain™ laryngeal mask versus a slit Guedel tube: a non-inferiority randomized-controlled trial. Moser, B., Audigé, L., Keller, C., et al.[2018]

In a study of 184 patients undergoing tracheal surgery, the use of a laryngeal mask airway (LMA) resulted in significantly shorter operative times compared to endotracheal tube (ETT) management (76.14 min vs 96.23 min).

Patients managed with LMA had lower rates of ICU admissions and shorter ICU stays, along with a reduced occurrence of postoperative dysphonia compared to those managed with ETT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laryngeal mask versus endotracheal tube for airway management in tracheal surgery: a case-control matching analysis and review of the current literature. Menna, C., Fiorelli, S., Massullo, D., et al.[2022]

In a study of 138 female patients undergoing elective pelvic laparoscopic surgery, the Laryngeal Mask Airway (LMA) Supreme was found to be more efficient than the Endotracheal Tube (ETT) in terms of airway management duration.

Post-operative pharyngolaryngeal morbidity, including hoarseness, was significantly lower in patients using the LMA Supreme compared to those using the ETT, indicating a safer option for airway management with reduced discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sparing the larynx during gynecological laparoscopy: a randomized trial comparing the LMA Supreme and the ETT. Abdi, W., Amathieu, R., Adhoum, A., et al.[2022]

In a study of 100 adult female patients undergoing laparoscopic cholecystectomy, the AMBU laryngeal mask (ALM™) demonstrated better haemodynamic stability compared to the classic laryngeal mask airway (CLMA™) during the exchange from endotracheal tube to laryngeal mask, with less significant increases in blood pressure and heart rate.

The ALM™ also provided a better glottic view than the CLMA™, making it a superior choice for this procedure, while both devices had similar rates of coughing, ease of placement, and post-operative sore throat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of classic laryngeal mask airway with Ambu laryngeal mask for tracheal tube exchange: A prospective randomized controlled study. Jain, S., Khan, RM., Ahmed, SM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02708836

Limiting Emergence Phenomena After General Anesthesia ... Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to limiting ...

2. trialx.com trialx.com/clinical-trials/listings/251227/limiting-emergence-phenomena-after-general-anesthesia-with-combined-lma-and-ett-airway-management-technique/

Limiting Emergence Phenomena After General Anesthesia ... Emergence from general anesthesia with a laryngeal mask airway compared with an endotracheal tube has been shown to favorable with respect to ...

3. withpower.com withpower.com/trial/phase-2020-f6855

Combined LMA + ETT Technique for Emergence ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5062217/

A prospective randomized control study comparing classic ... LMA™ is superior to OPA™ for exchange of ETT as it provides greater hemodynamic stability. Keywords: Airway extubation, airway management, laryngeal mask ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4529951/

I-gel Laryngeal Mask Airway Combined with Tracheal ... Utilization of I-gel combined with endotracheal tube in posterior fossa surgery patients is safe which can yield more stable hemodynamic profile ...

6. researchgate.net researchgate.net/publication/392413687_Investigation_of_Endotracheal_Tube_Versus_Laryngeal_Mask_Airway_Emergence_Times_for_Surgical_Patients

Investigation of Endotracheal Tube Versus Laryngeal Mask ... In this study, we aim to elucidate whether a difference in emergence times exists between using an ETT or LMA after general anesthesia.