SuperNO2VA™ nasal PAP ventilation system

Inadequate oxygenation/ventilation is the most common specific event seen in operating room claims and leads to a risk of hypoxemia which may cause more severe complications, such as brain damage or death1. The risk of hypoxemia also remains for patients after surgery, per a study conducted on noncardiac patients2.

The SuperNO2VA™ nasal PAP ventilation system delivers positive airway pressure to stent open the upper airway, allowing for the perioperative delivery of positive pressure ventilation and oxygen for patients with a decreased level of consciousness. The SuperNO2VA™ nasal PAP ventilation device is available in medium and large sizes and is offered as a standalone mask with a head strap and as a system, kitted with a hyperinflation bag. These configurations offer flexibility as it allows the SuperNO2VA™ nasal PAP ventilation device to be used with either an anesthesia machine or with only an oxygen flow meter.

Multi-Use

Can be used to deliver both nasal positive airway pressure and oxygen.

Portability

Kitted option requires only an oxygen source (flow meter or cylinder) to deliver oxygen and ventilation pressure support.

Flexibility

Available as a system to be connected direct to an oxygen flow meter as well as the device alone to be used with an anesthesia circuit.

There are several therapies used to reduce the risk of perioperative hypoxemia in adult patients. They include: CPAP/NIV, nasal PAP ventilation, nasal high flow, and other means of oxygen delivery (oxygen masks and oxygen nasal cannula). CPAP/NIV and nasal PAP devices deliver both positive pressure ventilatory support and oxygen.

Some of these therapies DELIVER OXYGEN, BUT NOT VENTILATORY SUPPORT. They include: nasal high flow oxygen therapy, and oxygen delivery via an oxygen mask or nasal cannula.

Ventilatory support may offer benefits for sedated patients at risk of hypoxemia due to upper airway obstruction. There are several studies which recommend the use of nasal CPAP (nCPAP) in particular versus oxygen delivery as it does not include a ventilatory support component.

Author and TitleTherapy ComparisonConclusion
Liang et al.
Nasal Ventilation Is More Effective than Combined Oral-Nasal Ventilation during Induction of General Anesthesia in Adult Subjects
Nasal mask ventilation versus oral-nasal mask ventilation "Nasal mask ventilation was more effective than combined oral-nasal mask ventilation in apneic, nonparalyzed, adult subjects during induction of general anesthesia. The authors suggest that nasal mask ventilation, rather than full facemask ventilation, be considered during induction of anesthesia."
Carron M. et al.
Perioperative noninvasive ventilation in obese patients: a qualitative review and meta-analysis
NIV/CPAP/PSV-PEEP versus standard oxygen therapy delivered through nasal cannula or (Venturi) mask (standard care) "Results from this review and meta-analysis suggest that NIV is well tolerated and effective in improving perioperative care in obese patients. The application of NIV before and after general anesthesia should be considered and promoted in relevant cases."
Mathru M. et al.
Magnetic Resonance Immaging of the Upper Airway: Effects of Propofol Anesthesia and Nasal Continuous Positive Airway Pressure in Humans
Nasal CPAP "In contrast to the traditional view that relaxation of the tongue causes airway obstruction, this study suggests that airway closure occurs at the level of the soft palate. Application of nasal CPAP can counteract an anesthesia-induced pharyngeal narrowing by functioning as a pneumatic splint. This is supported by the observed reduction in anteroposterior diameter at the level of the soft palate during propofol anesthesia and the subsequent increase in this measurement during nasal CPAP application."
Oto J. et al.
Continuous positive airway pressure and ventilation are more effective with a nasal mask than a full face mask in unconscious subjects: a randomized controlled trial
Nasal CPAP vs. full facemask CPAP "nCPAP (nasal CPAP) produced more effective tidal volume than FmCPAP (full facemask CPAP) in unconscious subjects."
Bohner H. et al.
Prophylactic nasal continuous positive airway pressure after major vascular surgery: results of a prospective randomized trial
Nasal CPAP versus oxygen mask or cannula "Prophylactic 12 h nCPAP (nasal CPAP) significantly reduces the occurrence of postoperative oxygenation disturbances but has no effect on cardiac or pulmonary complications, need for intensive care, LOS or mortality after major vascular surgery."
Smith S. et al.
A Pilot Study on the Effect of Nasal Continuous Positive Airway Pressure on Arterial Partial Pressure of Carbon Dioxide During Spinal Anesthesia with Intravenous Sedation for Total Knee Arthroplasty
Nasal CPAP versus oxygen mask "Deep sedation of TKA (total knee arthroplasty) patients during SAB (sub arachnoid block) resulted in moderate hypercarbia (mean and median PaCO2 = 55). There was a trend showing that nCPAP (nasal CPAP) treatment reduced PaCO2 versus treatment for control group patients receiving standard airway management; however, estimated treatment difference varied widely, from 1.4 to 12.6 mm Hg. Among control group patients, the initial PaCO2 during deep sedation was similar to the PaCO2 when measured after a 30-minute period of continued deep sedation. Finally, baseline PaCO2 among deeply sedated patients who received an airway was not different from that of patients who did not receive an airway."

Ghebremichael, S et al.
Evaluation of SuperNO2VA™ mask technology in a clinical setting: A pilot study. Trends in anaesthesia and critical care.

Conclusion

"This observational study demonstrated that the SuperNO2VA™ mask facilitates non-invasive positive pressure ventilation while providing adequate oxygenation and ventilation during preinduction, post-induction, laryngoscopy, and tracheal intubation in elective surgical patients. Conversely, considering the novelty of this particular study, further research is warranted to determine its usefulness in patients with known/predicted difficult airways, or even during emergent situations."


Kozinn, R. et al.
A Nasal Ventilation Mask for a morbidly obese patient with OSA and Atrial Fibrillation for Electrocardioversion: A case report.
Journal of Cardiothoracic and Vascular Anesthesia

Discussion

"The use of a nasal ventilation mask device as described here was performed on a morbidly obese patient with OSA undergoing deep sedation for electrical cardioversion, but it may be applicable to a variety of clinical settings. Such settings include the operating room, ICU, emergency department, and PACU. Using a hyperinflation bag attached to the nasal ventilation mask, as in this case, allows for continued positive pressure support during patient transport and during recovery in PACU, potentially minimizing complications in high-risk patient care areas. The outcome in this case is encouraging and suggests that a pressurized nasal ventilation mask may be used to improve oxygenation and ventilation in high-risk patients. Further well-designed studies are required to delineate its utility compared to standard anesthesia devices."


Pedro, M. et al.
Nasal variable positive airway pressure, a novel non-invasive airway technique to supplement deep sedation during endovascular therapy in a compromised pulmonary patient: A case report.
Journal of Anaesthesia and Critical Care Case Reports. 2017 May-Aug; 3(2):34‑38.

Conclusion

"Utilizing a sealed nasal mask connected to the anaesthesia machine, clinicians may provide nasal positive pressure to maintain upper airway patency and provide ventilatory support to patients under deep sedation. Using fresh gas flows of 10 l/min with a partially closed pop-off valve, this variable positive airway pressure technique provides expiratory pressure equivalent to that set by the pop-off valve with inspiratory pressure achieved passively from the circuit or augmented by manual squeezing of the reservoir bag. This technique may offer clinicians a non-invasive advantage to supplemental oxygen alone during deep sedation, particularly if patients have compromised pulmonary function or are at risk for upper airway collapse."


Posters and Case Studies

Afaneh, C. et al.
The SuperNO2VA™ Device decreases sedation-related hypoxemia during EGD in morbidly obese patients for pre-bariatric surgery screening: A case series.

Gidaro, M.
The SuperNO2VA™ for a morbidly obese patient with OSA for colonoscopy: A case report.

Rim, C. et al.
Use of the SuperNO2VA™ during prolonged intubation in a morbidly obese (MO) patient with unexpected difficult airway.

Hagberg, C. et al.
Evaluation of SuperNO2VA™ mask technology in a clinical setting.

Kozinn, R. et al.
The SuperNO2VA™ for a morbidly obese patient with OSA and Atrial Fibrillation for Electrocardioversion: A case report.

Cataldo, S.
Using the SuperNO2VA™ device to prevent re-intubation in the PACU: A case report.

Cataldo, S. et al
The SuperNO2VA™ maintains oxygenation and minimizes sedation related minute ventilation depression in obese patients during colonoscopy: A case series.

Gidaro, M. et al.
Nasal Positive Airway Pressure (VPAP), a novel noninvasive airway technique to supplement deep sedation during edovasciulaorf therapy in compromised pulmonary patient: A case report.

Kozinn, R. et al.
The SuperNO2VA™ nasal ventilation mask to decrease sedation-related hypoxemia in high-risk patients: A case series.

Cataldo, S. et al.
Using the SuperNO2VA™ device to facilitate awake fiberoptic intubation and provide post-operative nasal positive pressure in a patient with a difficult airway.

Foley, L.
Anticoagulation, Obstructive Sleep Apnea (OSA) and Airway Management: Case reports of patients with OSA undergoing A-V fistula formation or revision under deep sedation.

Rosenberg, L. et al.
Anesthetic management of a super-morbidly obese patient for ablation of insulinoma.

Cataldo, S. et al.
Treating respiratory compromise in the SICU with the SuperNO2VA™ following emergency anterior cervical spine surgery: A case report.

Lester, L. et al.
Use of nasal CPAP with the SuperNO2VA™ nasal anesthesia mask to alleviate airway obstruction during deep sedation for ablation for super ventricular tachycardia: A case report.

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