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Demonstrating the Feasibility of a Novel Oxygen Delivery Device

NCT02824211 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-10-14

No results posted yet for this study

Summary

Purpose: To investigate the feasibility of a new oxygen delivery device, the "Right Dose System" (RDS). It delivers individualized boluses of oxygen during rest and exertion to maintain acceptable oxygen saturations.

The procedures include: Enrollment of 10 patients, who are randomized to either exercise with their oxygen prescription followed by exercise with the RDS, or exercise with the RDS followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis. Each set of exercise will be separated by a 30 minute recovery session. Subjects will be adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will be above 18 years of age. Subject participation will last approximately 1 month. Subjects will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation program. Consent will take place in the pulmonary clinic, pulmonary function lab or pulmonary rehabilitation by trained study physicians. If Multi-center: N/A (single center) If Single center or investigator-initiated: 10 subjects will participate in the study.

Conditions

  • Increased Oxygen Demand

Interventions

DEVICE

Right Dose System

Automated titration of oxygen system during exertion

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Bryant Nguyen, MD, MS · Loma Linda University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2019-07-31
Completion
2020-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02824211 on ClinicalTrials.gov