Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

NCT02886312 | Completed FDA Device

• 1 other identifier: IRB_00083180
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.

Conditions

Oxygen Delivery; Patient Monitoring; Patient Comfort

Outcome Measures

Primary Outcomes (5)

• End-tidal Oxygen

  Did the novel system increase end-tidal oxygen?

  Continuously throughout 30 minute volunteer study

• Patient Comfort

  Did the patients feel it was more comfortable for a given end-tidal oxygen level?

  Every 2 minutes up to 30 minutes

• End-tidal Carbon Dioxide

  Was end-tidal carbon dioxide measured more accurately using the novel system?

  Continuously throughout 30 minute volunteer study

• Respiratory Rate

  Compared respiratory rate against capnometry.

  Continuously throughout 30 minute volunteer study

• Oxygen Saturation

  Did the novel system increase oxygen saturation?

  Continuously throughout 30 minute volunteer study

Interventions

Supplemental Oxygen Delivery System DEVICE

Eligibility Criteria

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

Study Population

Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

You may qualify if:

• Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah.

You may not qualify if:

• Volunteers who self report respiratory diseases such as acute respiratory distress syndrome, pneumonia and lung cancer will be excluded. In addition, volunteers who self report respiratory conditions such as nasal or bronchial congestion due to a cold or allergies will be excluded.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (3)

• Chanques G, Constantin JM, Sauter M, Jung B, Sebbane M, Verzilli D, Lefrant JY, Jaber S. Discomfort associated with underhumidified high-flow oxygen therapy in critically ill patients. Intensive Care Med. 2009 Jun;35(6):996-1003. doi: 10.1007/s00134-009-1456-x. Epub 2009 Mar 18.

  PMID: 19294365 BACKGROUND

• Sasaki H, Yamakage M, Iwasaki S, Mizuuchi M, Namiki A. Design of oxygen delivery systems influences both effectiveness and comfort in adult volunteers. Can J Anaesth. 2003 Dec;50(10):1052-5. doi: 10.1007/BF03018373.

  PMID: 14656787 BACKGROUND

• Burk KM, Sakata DJ, Kuck K, Orr JA. Comparing Nasal End-Tidal Carbon Dioxide Measurement Variation and Agreement While Delivering Pulsed and Continuous Flow Oxygen in Volunteers and Patients. Anesth Analg. 2020 Mar;130(3):715-724. doi: 10.1213/ANE.0000000000004004.

  PMID: 30633057 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 1, 2016
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 30, 2025

Record last verified: 2017-12

Locations

US (1)