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

NCT06713213 | Completed DMC

• 2 other identifiers: IRB # 24-813HRPP Protocol 24-813
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

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)

Conditions

Respiratory Failure With Hypoxia

Outcome Measures

Primary Outcomes (1)

• Measurement of Tidal volumes ( Minute Ventilation) and comparison of novel device with standard technology

  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)

  Through study completion, an average of 1 year.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• Comparison of tidal volume from nasal cavity diameter with statistical nasal cavity sizes

  Through study completion, an average of 1 year.

Study Arms (1)

Concomitant comparison of respiratory volumes using FRNDS device with Plethysmography belts

EXPERIMENTAL

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)

Other: Flow-regulated nasal oxygen delivery system (FRNDS)

Interventions

Flow-regulated nasal oxygen delivery system (FRNDS) OTHER

FRNDS is a novel cannula device that can both measure tidal volume (VT) in real time while simultaneously delivering air to the test subject. After collecting data without any flow through the FRNDS cannula for 2 minutes, varying amounts of medical air ( 21% Fio2) starting with 2 Liters for two minutes , 4 liters for 2 minutes, 6 liters for two minutes and 8 liters for two minutes would be delivered while monitoring and recording data previously described with the FRNDS device.

Concomitant comparison of respiratory volumes using FRNDS device with Plethysmography belts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be healthy adults over the age of 18.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Carilion Clinic: collaborator

Study Sites (2)

Carilion Clinic Center for Simulation, Research and Patient Safety

Roanoke, Virginia, 24012, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24016, United States

Location

Related Publications (4)

• Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.

  PMID: 27706466 BACKGROUND

• Agusti A, Vogelmeier CF. GOLD 2024: a brief overview of key changes. J Bras Pneumol. 2023 Dec 22;49(6):e20230369. doi: 10.36416/1806-3756/e20230369. No abstract available.

  PMID: 38126685 BACKGROUND

• Stevenson NJ, Walker PP, Costello RW, Calverley PM. Lung mechanics and dyspnea during exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1510-6. doi: 10.1164/rccm.200504-595OC. Epub 2005 Sep 15.

  PMID: 16166620 BACKGROUND

• Alobaidi NY, Stockley JA, Stockley RA, Sapey E. An overview of exacerbations of chronic obstructive pulmonary disease: Can tests of small airways' function guide diagnosis and management? Ann Thorac Med. 2020 Apr-Jun;15(2):54-63. doi: 10.4103/atm.ATM_323_19. Epub 2020 Apr 3.

  PMID: 32489439 BACKGROUND

Related Links

• Lamb K, Theodore D, Bhutta BS. Spirometry. \[Updated 2023 Aug 17\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
• Torp KD, Modi P, Pollard EJ, Simon LV. Pulse Oximetry. 2023 Jul 30. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. PMID: 29262014.
• Pulse Oximetry Klaus D. Torp; Pranav Modi; Elizabeth J. Pollard; Leslie V. Simon.

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: INTERVENTIONS: * RIP belts will be calibrated and outfitted on participants chests during each visit. RIP belts will be stored on-site and will be calibrated and outfitted by a designated member of the study * FRNDS cannulas will be placed inside nasal cavity, identical to clinical practices. FRNDS cannulas will be transported between the two sites according to participant enrollment * Digital calipers to measure both vertical and horizontal dimensions of the nasal cavity 1cm from the opening. Calipers will be appropriately cleaned before and after each use.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: December 3, 2024
• Study Start: April 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)