Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

Patient Comfort Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886312
• Other study ID #: IRB_00083180
• Status: Completed
• Phase: N/A
• First received: August 19, 2016
• Last updated: December 12, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Oxygen Delivery
• Patient Comfort
• Patient Monitoring

Intervention

Device:
• Supplemental Oxygen Delivery System

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-tidal Oxygen	Did the novel system increase end-tidal oxygen?	Continuously throughout 30 minute volunteer study
Primary	Patient Comfort	Did the patients feel it was more comfortable for a given end-tidal oxygen level?	Every 2 minutes up to 30 minutes
Primary	End-tidal Carbon Dioxide	Was end-tidal carbon dioxide measured more accurately using the novel system?	Continuously throughout 30 minute volunteer study
Primary	Respiratory Rate	Compared respiratory rate against capnometry.	Continuously throughout 30 minute volunteer study
Primary	Oxygen Saturation	Did the novel system increase oxygen saturation?	Continuously throughout 30 minute volunteer study