NCT06327373
Not yet recruiting
Phase 1
A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
Overview
- Phase
- Phase 1
- Intervention
- Room air
- Conditions
- Pulmonary Hypertension
- Sponsor
- Duke University
- Enrollment
- 10
- Locations
- 11
- Primary Endpoint
- Change daily hypoxemia burden
- Status
- Not yet recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults ≥18 years
- •Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
- •Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity \[TRV\] \>2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation \<90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to \<88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).
Exclusion Criteria
- •Daily supplemental oxygen use
- •Inability to provide informed consent
Arms & Interventions
Room air
Participants will receive no supplemental oxygen.
Intervention: Room air
Supplemental oxygen (0.5 liters per minute)
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
Intervention: Oxygen
Supplemental oxygen (3 liters per minute)
Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Intervention: Oxygen
Outcomes
Primary Outcomes
Change daily hypoxemia burden
Time Frame: Weeks 1, 2, and 3
Minutes with oxygen saturation \<90% over a 24-hour period assessed by pulse oximetry
Secondary Outcomes
- Change in six minute walk distance(Weeks 1 and 3)
- Change in Montreal Cognitive Assessment (MoCA)(Weeks 1 and 3)
Study Sites (11)
Loading locations...
Similar Trials
Completed
Not Applicable
Oxygen in Migraine TreatmentMigraine HeadacheOxygenNCT05780671Ankara Ataturk Sanatorium Training and Research Hospital160
Active, not recruiting
Not Applicable
Feasibility of providing additional oxygen in patients with resistant high blood pressure and obstructive sleep apnoeaObstructive sleep apnoea in patients with difficult-to-treat hypertensionNervous System DiseasesSleep apnoeaISRCTN51046126niversity of Oxford20
Completed
Not Applicable
Toward the Development of a Bronchoscope With a Dedicated O2 Channel ?BronchoscopyO2-supplementationNCT01963377Centre Hospitalier Universitaire Saint Pierre8
Terminated
Not Applicable
Feasibility and Acceptability of Oxygen Saturation Monitoring Using Masimo SafetyNet Alert (MSNA) in a Supportive Housing ProgramOpioid UseNCT06217380Masimo Corporation10
Completed
Not Applicable
Use of Blended Oxygen for Delivery Room Resuscitation of Very Low Birth Weight InfantsPrematurityOxidant InjuryNCT00369720Neil Finer40