NCT06713213: FRNDS

Clinical Comparison of Flow Regulated Nasal Oxygen Delivery System (FRNDS) Cannula and Plethysmography Belts

Completed NA Last updated 9 September 2025

What this trial tests

NA trial testing Flow-regulated nasal oxygen delivery system (FRNDS) in Respiratory Failure With Hypoxia in 57 participants. Completed in 1 August 2025.

Timeline

1 April 2025

Primary endpoint
1 August 2025

1 August 2025

Quick facts

Lead sponsor	Virginia Polytechnic Institute and State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	57
Start date	1 April 2025
Primary completion	1 August 2025
Estimated completion	1 August 2025
Sites	2 locations across United States

Drugs / interventions tested

• Flow-regulated nasal oxygen delivery system (FRNDS)

Conditions studied

• Respiratory Failure With Hypoxia — all drugs for Respiratory Failure With Hypoxia →

Sponsor

Virginia Polytechnic Institute and State University

Who can join

18 and older, any sex, with Respiratory Failure With Hypoxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Continuous non-invasive measurement of tidal volume and minute ventilation using a smart nasal cannula.
   Dogan AB, Patel N, Gottschalk C, Blankenship RL, et al · · 2025 · PMID 41310796 · DOI 10.1186/s13054-025-05757-1