Clinical Comparison of FRNDS Cannula and Plethysmography Belts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 57
- Locations
- 4
- Primary Endpoint
- Measurement of Tidal volumes ( Minute Ventilation) and comparison of novel device with standard technology
Study Overview
Brief Summary
SUMMARY:
This is a quantitative, non-inferiority study using healthy participants to compare tidal volumes at rest measured by both a standard RIP belt and a flow-regulated nasal oxygen delivery system FRNDS cannula.
Recording of tidal breathing is essential for patients undergoing evaluation for respiratory disease and reduced exercise capacity. Conventional spirometry techniques involving pneumotachometers are currently employed worldwide in pulmonary testing laboratories to record pulmonary flow and calculate tidal volumes by allowing subjects to breath out of mouth into these devices. However, concurrent use of pneumotachometers while testing a novel nasal device is not feasible. Respiratory inductive plethysmography (RIP) has been developed and validated to evaluate tidal ventilation during quiet breathing using a band around the chest. RIP signals may be contaminated by body movements resulting in artifacts which may be a limitation. However, although a crude method when compared to spirometry, RIP remains a viable method for comparison.
FRNDS is a novel cannula device that can both measure tidal volume (VT) in real time while simultaneously delivering air to the patient. The gold-standard of measuring VT clinically is spirometry; however, this test cannot be completed when patients are receiving supplemental oxygen or air.
Thus far, the FRNDS cannula has been tested in vitro with a cylindrical flow model and has accurately measured simulated VTs with 80% accuracy, but has not yet been validated in Human subjects. To assess the devices robustness in a clinical scenario is essential to the development and eventually adaptation of FRNDS in clinical care.
OBJECTIVES:-
In this study the investigators aim to describe and validate flow-regulated nasal oxygen delivery system (FRNDS) instrumented nasal cannula as a non-inferior methodology of measuring flows at the nasal interface compared to conventional methods (e.g., RIP belts) with the added benefit of administering a dose of air to the subjects.
While the FRNDS device was validated in vitro in a cylindrical model, the investigators aim to show equivalence to standard respiratory measurement methods in healthy subjects. This milestone will be essential towards the eventual translation of an adaptive cannula system that measures and adjusts air flow according to patient needs in real time.
ENDPOINTS:
The primary endpoint of this study is the continuous measurement of a test subjects Vt and Minute ventilation ( VE) while simultaneously delivering variable volumes of air to the patient and comparing these results with Vts and VE captured with conventional technology (RIP belts). The investigators will also be collecting inspiratory time (Ti) expiratory time (Te) continuously and a single measurement of nasal cavity openings (e.g., internal vertical and horizontal dimensions 1 cm inside the nares using calipers)
Detailed Description
STUDY DESIGN:
For each subject, over the 10-minute period the investigators will be collecting time-series data consisting of tidal volume (VT, VE derived from a fluid dynamics modeling equation based on pressure sensors and the measured diameter of the patient & nasal cavity), inspiratory time (Ti), and expiratory time (Te). Accordingly, minute ventilation will be calculated throughout the trial. Mean, standard deviation, and quartile (e.g., 25th, 50th, and 75th) measurements will be calculated after the trial is complete.
In addition, using the aforementioned measurements and the nasal cavity diameter measurements taken at the beginning of the trial, the investigators will be comparing the accuracy of the VT derived from our measure nasal cavity diameters and compare them to statistical nasal cavity sizes based on participant demographics (Corey et al. Otolayngol Head Neck Surg 1998; 119:389-93). Means, standard deviations, and quartile measurements will be compared between the measured and statistical nasal cavity diameter groups.
The data collected from RIP belts and the FRNDS cannula will be measured via descriptive statistics (e.g., mean, variance, standard deviation), a paired t-Test, Cross-Correlation Function, mean squared error (to determine absolute differences between measurements), and potentially dynamic time warping (DTW) to account for shifts and distortions in time.
METHODOLOGY:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants must be healthy adults over the age of 18.
Exclusion Criteria
- •Adults with preexisting comorbidities including:
- •Chronic lung disease
- •Chronic heart disease
- •Neuromuscular disease
- •History of nasal surgery
- •History of upper airway reconstructive surgery
- •History of deviated nasal septum
- •Preferential mouth breathers
- •Minors, as defined by state law where the study is performed (infants, children, teenagers)
- •Pregnant women will be excluded, as they have physiologically altered respiratory parameters and to minimize potential mechanical discomfort due to the RIP belts.
- •Prisoners (including all incarcerated individuals)
- •Adults not capable to consent on their own behalf
Outcomes
Primary Outcomes
Measurement of Tidal volumes ( Minute Ventilation) and comparison of novel device with standard technology
Time Frame: Through study completion, an average of 1 year.
Continuous measurement of a patients VT and Minute Ventilation while simultaneously delivering variable volumes of air to the subjects and comparing these results with VTs and Minute ventilation captured with conventional technology (RIP belts)
Secondary Outcomes
- Continuous measurement of Inspiratory time (Ti), and expiratory time (Te) and minute ventilation and comparison with standard technology(Through study completion, an average of 1 year.)