Advice

The technology

The technology

SuperNO2VA (Vyaire Medical) is a nasal positive airway pressure device designed to prevent and relieve upper airway obstruction. It is for use in patients with obstructive sleep apnoea throughout deep sedation, or during intubation and postoperatively in the post-anaesthesia care unit for those patients having general anaesthesia. Patients with obstructive sleep apnoea are at higher risk of upper airway obstruction, which could lead to hypoxaemia and other pulmonary complications. It is recommended by the company in the following circumstances:

  • Preoxygenation, intraoperative airway maintenance and postoperative support for patients having procedures needing deep sedation (such as endoscopy, cardiac ablations, pacemaker insertions, joint replacements, bronchoscopy, transoesophageal echocardiography, interventional radiology, magnetic resonance imaging and cystoscopy).

  • Preoxygenation and postoperative support for procedures needing tracheal intubation in patients with potentially and known difficult airways.

  • Postoperative support for patients in the post-anaesthesia care unit after operations needing general anaesthesia, such as bariatric, abdominal, thoracic and head and neck surgeries.

The device consists of a mask and head strap which can be connected to an anaesthesia breathing circuit in the operating theatre. A kitted option (containing the SuperNO2VA device, head strap and 2 litre hyperinflation system) allows the device to be used with an oxygen flow meter or cylinder outside of the operating theatre. It is available in medium and large sizes. It is designed to create a tight seal, deliver gas and provide positive pressure when placed over a patient's nose, aiming to maintain an open upper airway. It is intended for short-term use (less than 24 hours) on adult patients (who weigh more than 30 kg). The company claims that SuperNO2VA is able to:

  • preoxygenate

  • relieve upper airway obstruction because of a decreased level of consciousness (after general anaesthesia or deep sedation)

  • maintain ventilation or rescue ventilate

  • ease access for intraoral procedures

  • be used perioperatively without needing additional equipment.

The company state that SuperNO2VA should not be used for long-term ventilation or for treating obstructive sleep apnoea. It should also not be used if the patient has an allergy to any parts of the device, if the patient has a full stomach and is at high risk for aspiration, if the patient has complete nasal obstruction, if the patient is having nasal surgery, or if the patient has skin breakdown.

Innovations

The company states that SuperNO2VA aims to deliver both oxygen and ventilation, aiming to maintain a patent airway, which current standard facemasks, nasal cannulae and high flow nasal cannulae cannot achieve. It is portable and the company claims that it can also be used outside of the operating theatre. It may be used as an oxygen transport system in the postoperative care phase, without needing additional equipment.

Current care pathway

NICE's guideline on routine preoperative tests for elective surgery recommends that further research is needed about preoperative assessment and diagnosis of obstructive sleep apnoea, and whether this leads to preoperative intervention or improved postoperative outcomes.

The Association of Anaesthetists of Great Britain and Ireland's guidance on perioperative management of the obese surgical patient (2015) recommend that patients who may be at risk of obstructive sleep apnoea should be screened preoperatively. They recommend screening with the STOP-BANG questionnaire. The Society of Anaesthesia and Sleep Medicine guidelines (2016) state that in patients with obstructive sleep apnoea, perioperative positive airway pressure (PAP) should be used if resources allow, and consideration should be given to obtaining sleep study results and a recommended PAP setting before surgery. Further evaluation for preoperative cardiopulmonary optimisation may be needed for people with obstructive sleep apnoea who have uncontrolled comorbidities. In patients with obstructive sleep apnoea and controlled comorbidities, surgery can proceed providing that strategies to mitigate postoperative complications are implemented. The use of PAP therapy in previously undiagnosed but suspected obstructive sleep apnoea should be considered on a case-by-case basis.

The American Society of Anaesthesiologists's practice guidelines on perioperative management of patients with obstructive sleep apnoea recommend preoperative use of continuous positive airway pressure (CPAP) if obstructive sleep apnoea is severe. Postoperatively, CPAP with or without supplemental oxygen should be offered if it was needed preoperatively. Nasal CPAP should be considered in cases of frequent or severe airway obstruction or hypoxaemia during postoperative monitoring.

Postoperatively, The Royal College of Anaesthetists' Guidelines for the Provision of Postoperative Care 2019 state that patients with obstructive sleep apnoea should be monitored in a high-dependency unit because of a higher risk of postoperative complications such as hypoxia. They also state that the safety of obese patients postoperatively can be improved by including supplemental oxygen and CPAP in their care.

Population, setting and intended user

SuperNO2VA is aimed to maintain upper airway patency and reduce the risk of hypoxaemia in patients with obstructive sleep apnoea having general anaesthesia or deep sedation. According to the perioperative management of the obese surgical patient guidelines from the Association of Anaesthetists of Great Britain and Ireland, severe obstructive sleep apnoea happens in 10% to 20% of patients with a body mass index of more than 35 kg/m2 and is often undiagnosed. They also state that a diagnosis of obstructive sleep apnoea more than doubles a patient's risk of postoperative complications such as oxygen desaturation and respiratory failure.

Expert advice states that patients are identified as having obstructive sleep apnoea at a nurse-led preoperative assessment using screening questionnaire tools (such as the STOP-BANG questionnaire), with further referral for formal sleep polysomnography and optimisation on CPAP for patients having non-urgent elective surgery.

The device is intended to be used in secondary care by anaesthetists and operating theatre staff. Training is included in the cost of the device and is done by the company.

Costs

Technology costs

The costs of the SuperNO2VA device are outlined in table 1. All costs are presented excluding VAT. The unit cost for each SuperNO2VA device ranges from £23.25 to £37.75.

Table 1 SuperNO2VA Costs

Description

Quantity

Cost

Additional information

SuperNO2VA Nasal Interface (large)

20

£465.00

Consists of large sized SuperNO2VA device and head strap.

SuperNO2VA Nasal Interface (medium)

20

£465.00

Consists of medium sized SuperNO2VA device and head strap.

SuperNO2VA Satellite Kit (large)

20

£755.00

Consists of large sized SuperNO2VA device, head strap and 2 litre hyperinflation system.

SuperNO2VA Satellite Kit (medium)

20

£755.00

Consists of medium sized SuperNO2VA device, head strap and 2 litre hyperinflation system.

Costs of standard care

The cost of standard oxygen delivery devices are listed in table 2 and are estimates sourced from the company. According to clinical experts, patients who need home CPAP can use their own machine for use perioperatively.

Table 2 Costs of standard care

Description

Cost

Additional information

Facemask

£0.50

–

Nasal Cannula

£0.40

–

High Flow Nasal Cannula

£12.50

Additional costs include:

£17.50 for the circuit.

Service costs for additional capital equipment. This is factored into the consumable cost if equipment loaned free of charge.

Resource consequences

The company do not state any current NHS use of SuperNO2VA. The company states that SuperNO2VA costs more compared with current standard practice, however they claim greater benefits such as reduced need for further treatment, fewer adverse events and shorter hospital stay, that may be resource-releasing overall. There is no published evidence to support these claims.

According to a clinical expert, issues in adopting the device may be related to comfort and fit of the mask. CPAP is not tolerable for many patients, and the mask interface must be comfortable and able to create an adequate seal despite varying facial anatomy.