Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Dyspnea
  • Hypoxemia
  • Lung Diseases, Interstitial
  • Oxygen Inhalation Therapy
  • Pulmonary Disease, Chronic Obstructive
  • Pulmonary Fibrosis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Order of treatments tested will be randomized and only known to the person administering the study.Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 100 years
Gender
Both males and females

Description

Each participant will require (1) visit, which will last approximately 4-5 hours. At start of visit: Vitals are taken (temperature, heart rate, SpO2, respiration rate, blood pressure, Borg dyspnea score, Mmrc score) while participant is seated and using their normal oxygen prescription. Patient will...

Each participant will require (1) visit, which will last approximately 4-5 hours. At start of visit: Vitals are taken (temperature, heart rate, SpO2, respiration rate, blood pressure, Borg dyspnea score, Mmrc score) while participant is seated and using their normal oxygen prescription. Patient will remain seated during the following procedure with SpO2 and heart rate continuously being monitored. Pulsed Oxygen Control at Rest: Participant's oxygen will be turned off for 10 minutes as a washout period. Using the oxygen tank with the pulse regulator, the participant will be titrated to a pulse rate that maintains their SpO2 at an average of 95%. a. Increasing volumes of oxygen in 1 L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds. Once the participant is titrated to the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test. Mixed Continuous Air/Oxygen Efficacy at Rest: Participant's oxygen will be turned off for 10 minutes as a washout period. The participant will be delivered pulsed oxygen and high flow ambient air using the oxygen tank with the pulse regulator and Vapotherm setup, the participant will be titrated to a pulse rate that maintains their SpO2 at an average of 95%. High flow ambient air will be set to 15 L/min Increasing volumes of oxygen from in 1 L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds. Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes. Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test. Steps 5-8 are then repeated two more times for pulsed oxygen plus continuous flow ambient air at flow rates of 20 and 25 L/min. Mixed Pulsed Air/Oxygen Efficacy at Rest: Participant's oxygen will be turned off for 10 minutes as a washout period The participant will be delivered the out-of-phase pulsed oxygen and high flow ambient air using the oxygen tank with the pulse regulator and Vapotherm setup, the participant will be titrated to a pulse rate that maintains their SpO2 at an average of 95% High flow ambient air will be set to 15 L/min Increasing volumes of oxygen from in 1L/min increments every thirty seconds until an average of 95% SpO2 is maintained for 30 seconds. Once the participant is titrated the correct amount of oxygen, they will remain on the oxygen for an additional 3 minutes Final oxygen flow rate, SpO2, Heart Rate, and Borg Dyspnea Score will be recorded in the last minute of the test. Steps 10-13 are then repeated two more times for out-of phase pulsed oxygen plus pulsed high flow ambient air at flow rates of 20 and 25 L/min.

Tracking Information

NCT #
NCT04170062
Collaborators
Not Provided
Investigators
Principal Investigator: Sonye Danoff, MD, PhD Johns Hopkins University