FRNDS Cannula vs Plethysmography Belts for Respiratory Monitoring

(FRNDS Trial)

Recruiting at 1 trial location

Overseen By Umar F Sofi, M.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Chronic lung, heart, neuromuscular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

57 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy adults without chronic conditions, it's likely that participants are not on regular medications for such conditions.

What data supports the effectiveness of the treatment Flow-regulated nasal oxygen delivery system (FRNDS)?

Research on high-flow nasal cannula (HFNC) therapy, which is similar to FRNDS, shows that it can help reduce the work of breathing (the effort it takes to breathe) in patients with respiratory issues. This suggests that FRNDS might also be effective in improving breathing comfort and efficiency. ^{1 2 3 4 5}

Is the Flow-regulated nasal oxygen delivery system (FRNDS) safe for use in humans?

The research articles provided do not contain specific safety data for the Flow-regulated nasal oxygen delivery system (FRNDS) or its use in humans. ^{2 4 6 7 8}

How does the FRNDS treatment differ from other respiratory monitoring methods?

The FRNDS treatment is unique because it uses a flow-regulated nasal oxygen delivery system, which is different from traditional methods like plethysmography belts that measure breathing patterns. This system may offer a more direct and potentially more comfortable way to monitor and deliver oxygen to patients. ^{6 9 10 11 12}

What is the purpose of this trial?

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)

Eligibility Criteria

This trial is for healthy individuals to test a new nasal oxygen delivery system called FRNDS. It's designed for people who need their breathing measured while getting air or oxygen. Participants should not have respiratory failure or conditions that could interfere with the device's testing.

Inclusion Criteria

I am over 18 and in good health.

Exclusion Criteria

I have a chronic condition like lung or heart disease, or a history of nasal or airway surgery.

I am considered a minor in the state where the study takes place.

Prisoners (including all incarcerated individuals)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Measurement

Participants undergo continuous measurement of tidal volumes using FRNDS device and RIP belts

1 day

1 visit (in-person)

Data Analysis

Data collected from the FRNDS device and RIP belts is analyzed for accuracy and comparison

2-4 weeks

Follow-up

Participants are monitored for any adverse effects and results are shared

4 weeks

1 visit (virtual or in-person)

Treatment Details

Interventions

• Flow-regulated nasal oxygen delivery system (FRNDS)

Trial Overview The study tests if the FRNDS cannula can measure breath volumes as well as standard methods, like RIP belts, in healthy subjects. The goal is to see if it can accurately deliver and adjust airflow while measuring breathing without needing mouth-based spirometry.

Participant Groups

Group I: Concomitant comparison of respiratory volumes using FRNDS device with Plethysmography belts Experimental Treatment 1 Intervention

FRNDS is a novel cannula device that can both measure tidal volume (VT) in real time while simultaneously delivering air to the patient. Study subjects with undergo continuous measurement of a patient's VT while simultaneously delivering variable volumes of air to the patient and comparing these results with VTs captured with conventional technology (RIP belts)

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Carilion Clinic

Collaborator

Trials

85

Recruited

15,400+

Findings from Research

The ROX-HR index, which combines the ROX index with heart rate, shows promise in predicting treatment failure in patients using high flow nasal cannula (HFNC) for acute hypoxemic respiratory failure, with a significant association found at various time points after initiation of therapy.

A ROX-HR index greater than 6.80 at 10 hours is linked to a lower risk of HFNC failure, suggesting that this modified index could be a valuable tool for early intervention in at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early prediction of high flow nasal cannula therapy outcomes using a modified ROX index incorporating heart rate. Goh, KJ., Chai, HZ., Ong, TH., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A flow-leak correction algorithm for pneumotachographic work-of-breathing measurement during high-flow nasal cannula oxygen therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

FIO2 in an Adult Model Simulating High-Flow Nasal Cannula Therapy. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of High-Flow Nasal Cannula on the Work of Breathing in Patients Recovering From Acute Respiratory Failure. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Measurement of oxygen concentration delivered via nasal cannulae by tracheal sampling. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

The design of RIP belts impacts the reliability and quality of the measured respiratory signals. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Early prediction of high flow nasal cannula therapy outcomes using a modified ROX index incorporating heart rate. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

External nasal dilator decreases N95 respirator-related respiratory effort and symptoms in gastrointestinal endoscopy unit staff. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Fast integrated flow plethysmograph for small mammals. [2017]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Modelling mixing within the dead space of the lung improves predictions of functional residual capacity. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

[FRC measurement in intensive care patients. A definition of standards]. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Face mask application for calibration of respiratory inductive plethysmography in lambs. [2003]