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NCT06713213 · ClinicalTrials.gov registry record · NA
Clinical Comparison of Flow Regulated Nasal Oxygen Delivery System (FRNDS) Cannula and Plethysmography Belts
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
NCT06713213 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 57 participants.
The verdict
NCT06713213, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
Study 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 admin
Interventions
- OTHER Flow-regulated nasal oxygen delivery system (FRNDS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06713213
The ClinicalTrials.gov registry entry for NCT06713213 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Flow-regulated nasal oxygen delivery system (FRNDS) is the first listed.
NCT06713213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06713213 about?
NCT06713213 is a clinical study titled "Clinical Comparison of Flow Regulated Nasal Oxygen Delivery System (FRNDS) Cannula and Plethysmography Belts". 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 ...
What is the current status of trial NCT06713213?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2025-04-01. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT06713213?
The interventions under investigation include: Flow-regulated nasal oxygen delivery system (FRNDS) (OTHER).
Who is sponsoring clinical trial NCT06713213?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
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