SBIR-STTR Award

Capnometers can fail in a number of ways that are not detectable using current static calibration testing procedures. These failures could include leaks in the sample line, a weak sample pump, inadequate dynamic response, flow restriction and flow obstruction. Failure of a capnometer during critical care procedures such as sedation and anesthesia can be life threatening to patients. We plan to develop a patient breath simulator that will allow for the testing of capnometers under dynamic conditions seen during patient use. We propose to develop a portable device and control algorithms that will be capable of simulating CO2 concentrations and pressure waveforms mimicking human respiratory cycles. The same device will have additional testing modes that will identify capnometer failures that cannot be detected under static calibration. We propose to verify the ability of the device to detect real world failure modes by testing it on a number of capnometers that have been modified to simulate these failures. The ability to detect capnometer failures under real world conditions using an automated tester will improve patient safety as well as increase standardization of testing procedures and decrease testing and calibration costs.

Thesaurus Terms:
Affect;Algorithms;Anesthesia Procedures;Anesthesiology;Blinded;Blood Pressure;Breathing;Calibration;Carbon Dioxide;Cardiac;Cardiopulmonary;Caregivers;Clinical;Clinical Engineering;Cost;Cost Effective;Critical Care;Cues;Detection;Devices;Diagnosis;Documentation;Early Diagnosis;Effectiveness;Electrocardiogram;Ensure;Equipment;Evaluation;Failure (Biologic Function);Gas Analyzer;Gases;Human;Improved;Incidence;Lead;Life;Lung;Methods;Monitor;Obstruction;Patient Safety;Patient Simulation;Patients;Performance;Phase;Pressure;Prevent;Procedures;Process;Public Health Relevance;Pump;Repaired;Reporting;Research Study;Respiratory;Respiratory Therapy;Response;Risk;Sampling;Sedation Procedure;Sensor;Signal Transduction;Simulate;Simulation;Specificity;Standardization;System;Testing;Time;Work;

Respiratory gas monitors are being employed increasingly by healthcare providers to ensure respiratory health during critical care procedures such as sedation, mechanical ventilation and CPR. A malfunctioning gas monitor, which can be difficult to detect using traditional static test methods, can lead to serious injury or death. Current calibration and test methods are inadequate and cannot detect many critical fault conditions including leaks in the sampling system, a weak sample pump or valves, inadequate dynamic response and malfunctioning alarms. This project's focus is to develop a patient breath simulator that will allow for the testing of respiratory gas monitors under dynamic conditions encountered during patient use. The proposed device will be portable and will be capable of simulating O2, N2O, anesthetic agent and CO2 concentrations as well as pressure conditions mimicking human respiratory cycles. The same device will have additional testing modes that allow it to detect other critical faults. The proposed device will work with diverting gas monitors as well as on-airway gas monitors. The device is intended for use on both simple capnometers as well as multi-gas anesthesia monitors. The functionality of the proposed device will be verified through a series of bench tests on multiple gas monitors modified to introduce the various fault conditions. Additional verification will be done through usability studies with actua end users. The project will culminate in the beta testing of a larger sample of devices at a number of locations. Successful completion of this project will result in a final design for a marketable device that provides improved gas monitor testing and verification. The ability to detect gas monitor failures under real world conditions using an automated tester will improve patient safety, reduce risk for healthcare institutions, increase test procedure standardization and decrease testing/calibration costs.

Public Health Relevance Statement:


Public Health Relevance:
Respiratory gas monitors are being used increasingly by healthcare providers to monitor respiratory health during critical care procedures such as sedation, mechanical ventilation and CPR. A malfunctioning gas monitor, which can be difficult to detect using traditional static test methods, can lead to serious injury or death. We are developing a device that puts a gas monitor through a number of automated dynamic tests, checking for all critical fault conditions, to ensure that it is functioning properly and safe to ue on a critically ill patient.

Project Terms:
Anesthesia procedures; Anesthetics; Automation; Buffers; Calibration; Carbon Dioxide; Cessation of life; commercialization; Computers; Conscious Sedation; cost; Critical Care; Critical Illness; Data; design; Development; Devices; Documentation; Effectiveness; Ensure; Environment; Environmental air flow; exhaust; Failure (biologic function); Feedback; gas analyzer; Gases; Health Personnel; Healthcare; Heart Arrest; Hospitals; Human; improved; In Situ; Incidence; Injury; Institution; Instruction; Interview; Lead; Location; Marketing; Mechanical ventilation; Methods; Monitor; patient safety; Patients; Performance; Phase; Power Sources; Preparation; pressure; prevent; Procedures; Production; prototype; Provider; public health relevance; Pump; Qualifying; Quality Control; Regulation; Reporting; Research; research and development; respiratory; respiratory gas; respiratory health; response; Risk; Running; Safety; safety testing; Sampling; Sedation procedure; Series; standard of care; Standardization; success; System; Testing; Time; tool; usability; Validation; verification and validation; willingness; Work