Anesthesia Intraoral Module (AIM™)
Accurate, Reliable, 21st Century Monitor
AIM is an intra-oral device to deliver oxygen and capture exhaled carbon dioxide for capnography in sedated patients undergoing clinical procedures and require monitoring, per the safety guidelines of the American Society of Anesthesiologists (ASA).
Disclaimer: AIM is currently undergoing development and has not been approved by the FDA for patient use.
Anesthesia Intraoral Module (AIM)
Accurate and Reliable Monitoring for the High-Risk NORA Patients
AIM is an intra-oral device to deliver oxygen and capture exhaled carbon dioxide for capnography in sedated patients undergoing clinical procedures and require monitoring, per the safety guidelines of the American Society of Anesthesiologists (ASA).
Disclaimer: AIM is currently undergoing development and has not been approved by the FDA for patient use.
AIM for NORA
The volume and the complexity of the non-operating room anesthesia (NORA) cases continue to rise. The minimally invasive but complex NORA procedures often require deeper levels of sedation. Currently available devices offer insufficient oxygenation, unreliable capnography, and risk patient injuries during airway resuscitation. There is a growing and an unmet need for a next-generation monitoring device with enhanced patient-safety features offered at an attractive price point.
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How is AIM used?
AIM is specifically designed to be placed in the oral cavity, between the teeth of the upper and lower jaw, providing unique and significant advantages during sedation. Oxygen and capnography ports on AIM are connected to the oxygen supply line and the capnography monitor.
Higher FiO2
AIM offers an improved method of oxygen delivery by lowering the dead space, resulting in a higher FiO2 while utilizing significantly less oxygen than the commonly used devices. This feature could be of additional value in situations where oxygen conservation is essential.
Improved Capnography
Nasal cannulas stop functioning in patients converting to oral breathing. High-flow Nasal Cannulas do not monitor breathing. Face masks cause ETCO2 “washout” resulting in poor quality capnogram.
ETCO2 is the earliest indicator of airway compromise, including respiratory depression, apnea, and upper airway obstruction. (Burton, MD, Society for Academic Emergency Medicine 2006).
AIM’s intraoral placement offers two advantages. Uninterrupted capnography in patients breathing orally or nasally, and minimal CO2 washout, resulting in a capnogram that accurately reflects any breathing alterations in sedated patients.
Fewer Steps to Manage Hypoxia
Up to 54% of all NORA patients regardless of the ASA status, experience severe hypoxemia secondary to sedation-related upper airway obstruction and respiratory depression. (Urdaneta, MD Anesthesiology News Airway Management 2020).
The common response to hypoxia involves face mask removal, forced jaw opening in sedated patients, oral airway insertion, and replacing the face mask to resume oxygenation.
With AIM-enabled oral cavity access and oxygen flowing into the oropharynx, the response to hypoxia is a single step – placement of the oral airway – lowering patient injury risk and minimal procedural interruptions.
Facilitates Converting to General Anesthesia
Emergent conversion to general anesthesia occurs secondary to excessive patient movement, extreme discomfort, or respiratory failure.
During Transcatheter Aortic Valve Replacement (TAVR), a conversion rate of 5.9% from sedation to general anesthesia was reported. (Conscious Sedation Versus General Anesthesia for TAVR, Circulation, 2017).
A conversion rate of 9.8% was reported during mechanical thrombectomies. (Emergency Conversion to General Anesthesia, AJNR Am J Neuroradiology, Jan 2020).
An open oral cavity and oxygen flowing into the oropharynx, AIM replaces the traditional multi-step and injury-prone maneuvers to convert to general anesthesia.
MRI Compatibility
AIM is MRI compatible.
Eliminates the Need for Additional Bite-blocks
With a built-in bite block, endoscopy and TEE bite-blocks and awake fiber-optic intubation airways are not needed, saving time, resources as well as disposal of the additional, contaminated medical waste.
May Lower the Risk of Airway Fires
Nasal cannulas and face masks accumulate oxygen around patient’s face, risking airway fires, patient injuries and lawsuits. AIM’s oxygen flow directed into the oro-pharynx may help reduce the risk of airway fires.
Cost Savings
In the absence of safer alternatives, anesthesia providers frequently default to general anesthesia, adding costs, longer OR turnover, and recovery times.
For ambulatory anorectal surgery, the average hospital stay was 247 min for general anesthesia Vs. 116 min for sedation, a lower incidence of post-op nausea, and significantly higher patient satisfaction in the sedation group. (Comparison of the Costs of Ambulatory Anorectal Surgery, Anesthesiology 2000).
Conscious sedation for TAVR was associated with a total hospital stay of 4.9 days (Vs 10.4 for general anesthesia), nearly $14K in cost reduction, per case. (Improved costs, outcomes with sedation vs general anesthesia in TAVR patients, PLOS ONE, Apr 2017).
High FiO2 delivery, reliable capnography, and easy access to the oral cavity for airway resuscitation, AIM may help the anesthesia providers consider sedation, when appropriate.
Patient Satisfaction
Patient satisfaction is not only important, it is essential, as evidenced by the Centers for Medicare and Medicaid Services (CMS) payment program. Under this program hospitals are offered incentives for higher patient satisfaction scores.
AIM replaces face masks and bite blocks strapped around a patient’s neck, and can reduce anxiety in patients who are claustrophobic and those who don’t tolerate face mask placement.
Logistical Issues
With increased safety and versatility, AIM could help with the logistical challenges faced by the hospitals while dealing with multiple vendors, stocking of multiple devices, product availability and the price changes.
Lower Environmental Impact
With a much smaller surface area and compact form, compared to the face masks and the high-oxygen flow devices, the AIM device consumes fewer manufacturing resources and raw materials. Additionally, by eliminating the need for endoscopy and TEE bite-blocks and awake fiberoptic-intubation airways, AIM further lowers the environmental impact by reducing the number of contaminated disposables.
