Distal Pharyngeal Airway for Oxygenation During Procedures

Overseen by Fouad G Souki, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Uncontrolled GERD, Airway obstruction, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new flexible tube called the McMurray Enhanced Airway (MEA) to help people breathe better. It aims to see if this tube can deliver oxygen more effectively than the usual method. The MEA is designed to reach deeper into the throat, which might improve oxygen levels in patients who need it.

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 data supports the effectiveness of the treatment Distal Pharyngeal Airway for Oxygenation During Procedures?

The study on Transnasal Humidified Rapid Insufflation Ventilatory Exchange (THRIVE) with a nasopharyngeal airway showed that it effectively kept the airway open during anesthesia-induced apnea, suggesting that similar airway devices can help maintain oxygen levels during procedures. ^{1 2 3 4 5}

Is the Distal Pharyngeal Airway safe for use in humans?

The Distal Pharyngeal Airway (DPA) is designed to prevent airway obstruction during procedures, especially in patients with higher risk factors like older age and sleep apnea. While specific safety data for the DPA is not detailed, it is intended to maintain ventilation, suggesting a focus on safety in its design. ^{6 7 8 9 10}

How is the McMurray Enhanced Airway treatment different from other airway management treatments?

The McMurray Enhanced Airway (MEA) is unique because it is designed to stent open the distal pharyngeal tissues, preventing airway obstruction during procedures, especially in patients with conditions like obstructive sleep apnea. This is different from other airway devices that may not specifically target the distal pharyngeal area to maintain ventilation. ^{6 9 11 12 13}

Research Team

Fouad G Souki, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

I am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• McMurray Enhanced Airway (Procedure)
• Nasal Cannula (Procedure)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transnasal Humidified Rapid Insufflation Ventilatory Exchange With Nasopharyngeal Airway Facilitates Apneic Oxygenation: A Randomized Clinical Noninferiority Trial. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Dynamic comparison of pharyngeal stability during sleep in patients with obstructive sleep apnea syndrome treated with maxillomandibular advancement. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Optimising the unprotected airway with a prototype Jaw-Thrust-Device--a prospective randomised cross-over study. [2009]

4. Germany pubmed.ncbi.nlm.nih.gov

Volumetric analysis of the pharynx in patients with obstructive sleep apnea (OSA) treated with maxillomandibular advancement (MMA). [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical study on modified maxillomandibular advancement for the treatment of obstructive sleep apnea syndrome]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Introducing the First Distal Pharyngeal Airway. [2023]

7. Korea (South) 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. [2022]

8. United States 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Anaesthesia for adenotonsillectomy: a comparison between tracheal intubation and the armoured laryngeal mask airway. [2022]

10. United States 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. [2023]

11. India pubmed.ncbi.nlm.nih.gov

ProSeal laryngeal mask airway improves oxygenation when used as a conduit prior to laryngoscope guided intubation in bariatric patients. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Successful pharyngeal pulse oximetry in low perfusion states. [2004]

13. Germany pubmed.ncbi.nlm.nih.gov

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