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InspirAlertTM and SealVisionTM: Simple and Unique Optimized Biofeedback in an Improved pMDI Aerosol Delivery System — Newhouse M et al4

Purpose:

To provide biofeedback that encourages patients and caregivers to optimize aerosol therapies with pressurized metered dose inhalers (pMDIs).

  1. Audible signals indicating that inhalation is too rapid.
  2. Visual indication of mask-to-face seal prior to pMDI activation, especially important for caregivers with young children.
Design:

InspirAlert Audible Signal

  • InspirAlert is a unique whistle in the InspiraChamber® VHC that indicates excessively rapid inhalation
  • InspirAlert may also be used as an auditory threshold training tool for patients when learning to correctly inhale through the VHC + pMDI

SealVision Visual Indicator

  • A brightly colored integral flap on SootherMaskTM and InspiraMaskTM
    • Its vertical excursion on exhalation confirms the face-to-mask seal
Methods:

Auditory Signal

  • InspirAlert was compared to reeds in AeroChamber Plus® Flo-Vu® (AC), OptiChamber® Advantage (OC), and OptiChamber Diamond (OD) with 5 pMDIs to obtain biofeedback thresholds
  • A vacuum was applied to each VHC mouthpiece and each VHC + pMDI combination was tested 3 times by 3 observers (n=9)
  • Flow at which observers first heard the audible signal was recorded using a digital flow meter

Visual Signal

  • Using a Flovent® pMDI (without dose counter), medium InspiraMask with SealVision was compared to medium AC with mask and OD with LiteTouch mask

Expiratory Signal

  • Because SealVision on InspiraMask and OD are activated upon exhalation, compressed air was applied to the same face model to simulate exhalation
  • 40 flow determinations were obtained by 4 observers (10/person for each VHC + mask) for ‘detectable movement’ with each seal indicator or exhalation valve
Results:

InspirAlert

  • Sound threshold varies with flow due to variability in resistance between canister and actuator (i.e. air entrainment) between pMDIs
InspirAlert is a unique cylindrical solid-state whistle that indicates rapid inhalation InspirAlert is a unique cylindrical solid-state whistle that indicates rapid inhalation
  • InspirAlert sounds at flows more clinically appropriate versus AC and OC audible reeds

Study Conclusion: The InspiraChamber InspirAlert is a unique cylindrical solid-state whistle that indicates rapid inhalation at a lower inspiratory flow, more clinically appropriate than both AC and OC. It may also be a useful teaching tool

Results:

SealVision

  • The SealVision visual indicator on SootherMask and InspiraMask is readily visible with minimal inspiratory effort at flow velocity as low as 0.05 L/sec*, considerably less than AC and OD, indicating that SealVision is appreciably more sensitive
SealVision on SootherMask and InspiraMask is a sensitive visual indicator SealVision on SootherMask and InspiraMask is a sensitive visual indicator

Study Conclusion: SealVision on SootherMask and InspiraMask is a sensitive visual indicator confirming an adequate face-to-mask seal at very low inspiratory flow

 ADVAIR is registered to Glaxo Group Limited.
 AEROCHAMBER PLUS and AEROCHAMBER PLUS FLOW-VU are registered to Trudell Medical International.
 ATROVENT is registered to Boehringer Ingelheim International GmbH.
 FLOVENT is owned by Glaxo Group Limited.
 INSPIRACHAMBER, INSPIRAMASK and SOOTHERMASK are registered to InspiRx, Inc.
 OPTICHAMBER ADVANTAGE and OPTICHAMBER DIAMOND are registered to Respironics Inc.
 QVAR is a trademark of Ivax LLC.
 VORTEX is registered to PARI GmbH.
INDICATIONS FOR USE

InspiraChamber Anti-Static Valved Holding Chamber (VHC) is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The intended environments are the home, hospitals and clinics.

Cautions:
  • Do not leave InspiraChamber, SootherMask or InspiraMask unattended with children.
Notes:
  • Storage and operating range: 5°C–40°C (41°F–104°F) at 15–95% relative humidity.
  • Inspect the device for cracks, debris, or damage that will prevent proper function after each cleaning. REPLACE IMMEDIATELY if any damages are observed. Environmental conditions, storage and proper cleaning can affect device life span.
  • This medical device is for single-patient use.
  • The intended patient population for InspiraChamber with Mouthpiece is three (3) years and older who have been prescribed pMDI medications.
  • The size of the SootherMask or InspiraMask should be determined by the size of the patient’s face.
  • If medication build-up is observed in your chamber, wash the inside of the chamber with a soft cloth according to the Instructions for Use to ensure proper performance.