Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT02886312
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxygen Delivery; Patient Monitoring; Patient Comfort	Device: Supplemental Oxygen Delivery System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Primary Purpose: Supportive Care
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Outcome Measures

Primary Outcome Measures

1. End-tidal Oxygen [Continuously throughout 30 minute volunteer study]

   Did the novel system increase end-tidal oxygen?

2. Patient Comfort [Every 2 minutes up to 30 minutes]

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

3. End-tidal Carbon Dioxide [Continuously throughout 30 minute volunteer study]

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

4. Respiratory Rate [Continuously throughout 30 minute volunteer study]

   Compared respiratory rate against capnometry.

5. Oxygen Saturation [Continuously throughout 30 minute volunteer study]

   Did the novel system increase oxygen saturation?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Joseph Orr, Ph.D., University of Utah
• ClinicalTrials.gov Identifier: NCT02886312
• Other Study ID Numbers: IRB_00083180
• First Posted: Sep 1, 2016
• Last Update Posted: Dec 14, 2017
• Last Verified: Dec 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Dec 14, 2017