FRNDS Cannula vs Plethysmography Belts for Respiratory Monitoring

(FRNDS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new device, the FRNDS cannula (flow-regulated nasal oxygen delivery system), can measure breathing as accurately as current methods like plethysmography belts. The FRNDS cannula not only measures inhaled air but also delivers oxygen, which could benefit those needing supplemental oxygen. The goal is to ensure this new device performs as well as existing tools for tracking breathing. Healthy adults without a history of nasal surgeries or major health issues related to the lungs, heart, or muscles are ideal candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative medical technology.

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 prior data suggests that the FRNDS cannula is safe for respiratory monitoring?

Research shows that the FRNDS cannula is a new tool designed to measure air intake and output while also providing air. It has been tested in a lab using a model and has achieved about 80% accuracy in measuring breathing. However, it has not yet been tested on people.

Similar devices, such as high-flow nasal cannulas, have been used safely in hospitals. Studies have shown they work well and are safe for delivering oxygen to patients in need. This suggests that the FRNDS cannula might also be safe for people, but further testing is necessary.

The current study aims to determine if the FRNDS cannula performs as well as other methods and if it is safe for healthy individuals. Since it is being tested on healthy participants, it is likely considered low-risk. However, it remains a new device and has not been approved for general use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FRNDS device because it offers a new way to monitor and support breathing. Unlike traditional methods like plethysmography belts, which only measure respiratory volumes, the FRNDS device can both measure tidal volume in real time and deliver variable amounts of air to the patient. This dual function could provide more accurate monitoring and better respiratory support, potentially leading to improved patient outcomes.

What evidence suggests that the FRNDS cannula is effective for respiratory monitoring?

This trial will compare the Flow-regulated nasal oxygen delivery system (FRNDS) with Plethysmography belts for respiratory monitoring. Studies have shown that high-flow nasal cannulae, which are special tubes delivering oxygen, can lower the breathing rate and improve oxygen levels. They ease breathing and increase lung air volume. The new FRNDS device builds on this concept, designed to measure breathing while providing additional air. In lab tests, the FRNDS device accurately measured breathing 80% of the time compared to standard methods. This suggests that FRNDS might be a good option for measuring breathing in real-life situations, especially for those needing extra oxygen. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 am not pregnant, as pregnancy affects the study's requirements.

Prisoners (including all incarcerated individuals)

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06713213?term=Virginia+Little

Clinical Comparison of Flow Regulated Nasal Oxygen ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/f8ed6ed96a092d0a/nct06713213-clinical-comparison-nasal-oxygen-delivery

Clinical Comparison of Flow Regulated Nasal Oxygen ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8060689/

Accuracy of noncontact surface imaging for tidal volume ... Nasal high flow oxygen therapy in patients with COPD reduces respiratory rate and tissue carbon dioxide while increasing tidal and end ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217325813

Oxygen delivery through high-flow nasal cannulae ... This study suggests that HFNCs reduce respiratory rate and improve oxygenation by increasing both EELV and tidal volume and are most beneficial in patients ...

5. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-025-05366-y

Physiological comparison of noninvasive ventilation and high ... In patients at high-risk of extubation failure, prophylactic NIV significantly decreased inspiratory efforts with increased tidal volumes compared to HFNO.

6. ctv.veeva.com ctv.veeva.com/study/clinical-comparison-of-flow-regulated-nasal-oxygen-delivery-system-frnds-cannula-and-plethysmograp

Clinical Comparison of Flow Regulated Nasal Oxygen ... FRNDS is a novel cannula device that can both measure tidal volume (VT) in real time while simultaneously delivering air to the patient.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5537116/

High-flow nasal oxygen therapy and noninvasive ... HFNC can deliver high FiO2 compared to other oxygen delivery systems, through a higher flow rate, up to 70 L/min, which in most cases exceeds the patient peak ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2531043723000077

Efficacy and safety of high-flow nasal cannula therapy in ... HFNC is an effective and safe alternative in elderly patients with ARF not due to COVID-19, refractory to treatment with conventional oxygen therapy and/or ...

9. link.springer.com link.springer.com/article/10.1007/s10877-021-00708-x

Accuracy of noncontact surface imaging for tidal volume ... Time-of-flight camera enables continuous and non-contact respiratory monitoring under high-flow nasal canula, and enables to detect tidal volume ...