Distal Pharyngeal Airway for Oxygenation During Procedures

Overseen By Fouad G Souki, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Uncontrolled GERD, Airway obstruction, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: up to 60 minutes

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the McMurray Enhanced Airway (MEA) to determine if it delivers oxygen more effectively than the standard nasal cannula during certain medical procedures. The researchers aim to assess whether the MEA improves oxygen delivery during a transesophageal echocardiogram (TEE), a procedure using sound waves to create heart images. Participants scheduled for an elective TEE procedure and willing to consent may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative research that could enhance patient care during heart imaging procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the McMurray Enhanced Airway is safe for improving oxygen delivery?

Research has shown that the McMurray Enhanced Airway (MEA) is generally easy for patients to handle. One study found it successfully kept airways open for 95% of patients, indicating it worked well for most people. The study also reported that most healthcare providers were satisfied with the device's performance. No major reports of serious side effects or problems have emerged from its use. The MEA is designed to improve oxygen delivery, especially during procedures requiring sedation, making it a promising option for those needing enhanced oxygen support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the McMurray Enhanced Airway because it offers a new way of delivering oxygen during procedures like transesophageal echocardiography (TEE). Unlike the standard nasal cannula, which delivers oxygen through the nose, the McMurray Enhanced Airway provides oxygen directly to the distal pharyngeal airway, potentially improving oxygenation efficiency. This method might enhance patient comfort and oxygen delivery during the procedure, which is why it's generating interest.

What evidence suggests that the McMurray Enhanced Airway is effective for improving oxygen delivery?

Research has shown that the McMurray Enhanced Airway (MEA), which participants in this trial may receive, effectively keeps the airway open. One study found it worked 95% of the time, while another study reported 100% success in maintaining a clear airway during use. This evidence suggests that the MEA can improve oxygen delivery by stabilizing the airway. Additionally, most users found it easy to use and effective in preventing breathing problems during procedures. ^{1 4 5 6 7}

Who Is on the Research Team?

Fouad G Souki, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who are scheduled for an elective Transesophageal Echocardiography (TEE) procedure and can give informed consent. It's not suitable for those with uncontrolled acid reflux or anatomical airway blockages, or any condition that might interfere with the study.

Inclusion Criteria

I am willing to join the study and can give my consent.

I am scheduled for a TEE (heart ultrasound) procedure.

Exclusion Criteria

Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

I have uncontrolled acid reflux.

I have a blockage in my airways.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a TEE procedure with either the McMurray Enhanced Airway or a nasal cannula for oxygen delivery

up to 60 minutes

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• McMurray Enhanced Airway
• Nasal Cannula

Trial Overview The study is testing if the McMurray Enhanced Airway (MEA), a special flexible airway device, provides better oxygenation during TEE than the standard nasal cannula, which is a tube placed in the nostrils.

How Is the Trial Designed?

Group I: Distal Pharyngeal Airway Experimental Treatment 1 Intervention

Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.

Group II: Nasal cannula group Active Control 1 Intervention

Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.

McMurray Enhanced Airway is already approved in United States for the following indications:

Approved in United States as McMurray Enhanced Airway for:

• Airway management for anesthesia
• Emergency medical services (EMS)
• Endoscopy procedures

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study involving 109 children undergoing adenotonsillectomy, the prototype armoured laryngeal mask airway (LMA) provided a quicker and satisfactory airway management compared to tracheal intubation, with a significant reduction in the time required for ventilation (P < 0.001).

The LMA group experienced lower heart rates and mean arterial pressure during the procedure, indicating potentially less physiological stress compared to the tracheal intubation group, which had higher rates of complications such as airway obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthesia for adenotonsillectomy: a comparison between tracheal intubation and the armoured laryngeal mask airway. Webster, AC., Morley-Forster, PK., Dain, S., et al.[2022]

In a systematic review of 15 studies involving 1263 patients, both the ProSeal laryngeal mask airway (PLMA) and the streamlined liner of the pharynx airway (SLIPA) showed similar rates of successful insertion and airway sealing pressure during general anesthesia.

However, the PLMA had a shorter insertion time and a lower incidence of blood staining compared to SLIPA, suggesting it may be the more advantageous option for airway management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Laryngeal Mask Airway ProSeal and the Streamlined Liner of the Pharynx Airway During General Anesthesia: A Systematic Review and Meta-analysis. Jiang, M., Qiao, A., Liang, W., et al.[2023]

In a study involving 123 patients, the use of a nasopharyngeal airway (NPA) was found to be noninferior to the jaw thrust technique for maintaining airway opening during anesthesia-induced apnea, as measured by oxygen (PaO2) and carbon dioxide (PaCO2) levels after 20 minutes.

Both methods effectively maintained safe oxygen levels (PaO2) and prevented dangerous carbon dioxide buildup (PaCO2), with no patients experiencing oxygen saturation below 90%, indicating that NPA is a safe alternative for airway management in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial. Chen, L., Yang, L., Tian, W., et al.[2020]

Pharyngeal oximetry using a laryngeal mask airway was successfully performed in two patients with low perfusion states, where traditional finger oximetry was ineffective.

This method provided reliable oxygen saturation readings, only 0-2% lower than arterial samples, demonstrating its feasibility as an alternative monitoring technique in critical care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful pharyngeal pulse oximetry in low perfusion states. Brimacombe, J., Keller, C.[2004]

In a study involving 121 minor pediatric otolaryngology operations, primarily adeno-tonsillectomies, the reinforced laryngeal mask airway was successfully used in 117 cases, demonstrating its effectiveness as an alternative to tracheal intubation.

The complication rate was low, with only four instances requiring tracheal intubation and a 4.1% rate of ventilation issues, suggesting that the laryngeal mask airway is a safe option for these procedures when managed by experienced anesthetists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experiences with use of the laryngeal mask with flexible, wire reinforced tube for ENT interventions in childhood]. Wehrle, HJ., Gottstein, P.[2013]

The streamlined liner of the pharynx airway (SLIPA) showed a first insertion success rate of 73.3%, compared to 93.3% for the ProSeal laryngeal mask airway (PLMA), indicating that PLMA may be easier to use during general anesthesia.

Despite the lower success rate, SLIPA had comparable efficacy in terms of lung mechanics and complication rates, but it was associated with a higher incidence of blood stains on the device (40% for SLIPA vs. 6.7% for PLMA), suggesting a potential safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of the streamlined liner of pharyngeal airway (SLIPA) compared with the laryngeal mask airway ProSeal during general anesthesia. Choi, YM., Cha, SM., Kang, H., et al.[2022]

The flexible laryngeal mask airway (FLMA) shows advantages over endotracheal intubation (ETT) in reducing hoarseness, coughing, and oxygen desaturation during recovery, based on a meta-analysis of 10 randomized controlled trials.

However, the FLMA is associated with a higher incidence of partial upper airway obstruction compared to ETT, indicating that while it has benefits, caution is needed in certain surgical situations, especially for patients at high risk for aspiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway Complications during and after General Anesthesia: A Comparison, Systematic Review and Meta-Analysis of Using Flexible Laryngeal Mask Airways and Endotracheal Tubes. Xu, R., Lian, Y., Li, WX.[2018]

Maxillomandibular advancement (MMA) surgery significantly increased the size of the pharynx during sleep by 66% in patients with obstructive sleep apnea, indicating improved airway space.

Post-surgery, the variability in the pharyngeal measurements decreased from 117.5% to 51%, suggesting enhanced stability of the airway and a reduced risk of pharyngeal collapse during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic comparison of pharyngeal stability during sleep in patients with obstructive sleep apnea syndrome treated with maxillomandibular advancement. Faria, AC., Garcia, LV., Santos, AC., et al.[2022]

The Jaw-Thrust-Device significantly improved expiratory tidal volumes and peak inspiratory flow during facemask ventilation compared to the standard Esmarch manoeuvre in a study of 50 healthy adults.

It also outperformed both nasopharyngeal and oropharyngeal airways in reducing airway resistance, indicating its potential as a more effective tool for maintaining airway patency during anesthesia induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising the unprotected airway with a prototype Jaw-Thrust-Device--a prospective randomised cross-over study. von Goedecke, A., Mitterschiffthaler, L., Paal, P., et al.[2009]

In a study of 40 morbidly obese patients undergoing bariatric surgery, the ProSeal™ laryngeal mask airway (PLMA) significantly improved arterial oxygenation compared to the facemask (FM), with 95% of patients in the PLMA group maintaining oxygen saturation above 90%.

The use of PLMA resulted in a higher pO2 and fewer difficulties in ventilation compared to FM, indicating it may be a safer and more effective option for airway management in morbidly obese patients during anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ProSeal laryngeal mask airway improves oxygenation when used as a conduit prior to laryngoscope guided intubation in bariatric patients. Sinha, A., Jayaraman, L., Punhani, D., et al.[2021]

The new distal pharyngeal airway (DPA) device is designed to prevent airway obstruction during anesthesia, which is crucial for maintaining adequate ventilation, especially in patients who are older, heavier, or have obstructive sleep apnea.

As airway obstruction is a common and serious issue during anesthesia, the DPA addresses the risk by physically stenting open the distal pharyngeal tissues, thereby improving safety for patients undergoing procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing the First Distal Pharyngeal Airway. McMurray, RR., McMurray, MR.[2023]

Maxillomandibular advancement (MMA) surgery significantly increases the pharyngeal air space in patients with obstructive sleep apnea (OSA), with a mean volumetric increase of 26.72% in the retropalatal region and 27.2% in the retrolingual region, as measured by magnetic resonance imaging in a study of 20 patients.

The anatomical changes from MMA surgery help reduce the collapsibility of the pharynx during breathing, which may lead to fewer obstructive events and improved breathing during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric analysis of the pharynx in patients with obstructive sleep apnea (OSA) treated with maxillomandibular advancement (MMA). Faria, AC., da Silva-Junior, SN., Garcia, LV., et al.[2022]

The modified maxillomandibular advancement (MMMA) technique significantly reduced the apnea-hypopnea index from an average of 40.1 to 5.4 events per hour in eight patients with obstructive sleep apnea syndrome (OSAS), indicating its efficacy in treating severe cases.

Postoperative results showed improved oxygen saturation levels, increasing from 72.4% to 90.6%, while also minimizing facial profile changes compared to traditional MMA techniques, making this approach more appealing for patients considering surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study on modified maxillomandibular advancement for the treatment of obstructive sleep apnea syndrome]. Li, Y., Yi, B., Wang, X., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05974488

The Efficacy of Distal Pharyngeal Airway for Oxygenation ... The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway (MEA) which is a flexible extended-length distal pharyngeal airway ...

2. medrxiv.org medrxiv.org/content/10.1101/2020.11.20.20222018.full

A Survey of Provider Satisfaction of a New, Flexible ... The novel airway device was 95% successful in establishing and maintaining a patent airway (n=68). Survey responses indicated that the airway ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10306336/

Introducing the First Distal Pharyngeal Airway - PMC The DPA (McMurray Enhanced Airway, McMurray ... New distal pharyngeal airway contributes to improved patient care and outcomes: 2 case reports.

4. researchgate.net researchgate.net/publication/382635328_Use_and_Evaluation_of_the_McMurray_Enhanced_Airway_-_Distal_Pharyngeal_Airway_for_Improved_Airway_Management_Under_Deep_Sedation_in_the_Endoscopy_Clinic

Use and Evaluation of the McMurray Enhanced Airway The primary outcome was the incidence of transient hypoxia during the procedure. The secondary outcomes covered the hemodynamics, time ...

5. mcmurraymed.com mcmurraymed.com/in-the-news

In the News 100% successful in establishing and maintaining a patent airway (n=86) · 93% of respondents agreed that the MEA was easy to place · 98% allowed for a “hands-off ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2210844024000443

Use and evaluation of the McMurray enhanced airway This project shows that the DPA was useful in managing airway obstructions and most providers expressed overall satisfaction with its function.

7. mcmurraymed.com mcmurraymed.com/

McMurray Medical | MEA Distal Pharyngeal Airway (DPA) The MEA is an innovative distal pharyngeal airway (DPA) designed to help improve safety, outcomes, provider satisfaction and reduce healthcare costs.