AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
NCT ID: NCT04649775
Last Updated: 2022-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2021-04-09
2021-11-08
Brief Summary
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Detailed Description
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This is an unblinded, randomized, controlled trial for use of the AirFLO2 device for patients admitted to Duke Hospital with COVID-19 and tachypnea (RR \>20 breaths/min) and/or hypoxia (Oxygen saturation \<94% on room air or requiring supplemental oxygen at baseline).
Groups will be analyzed by intention to treat. Per-protocol analyses will also be performed. Descriptive statistics will be reported for the overall subject population, and for the two groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Device intervention
Intervention participants will receive the AirFLO2 device and training via video with reinforcement from the coordinator how to use and to self-apply it. Clinical data will be recorded before and after intervention. Questionnaires will be completed at baseline and at serial time points after intervention starts.
AirFLO2
Mask device
Standard of Care- Control
Participants will receive standard of care, clinical data will be recorded. Baseline and end of study questionnaires will be performed.
No interventions assigned to this group
Interventions
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AirFLO2
Mask device
Eligibility Criteria
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Inclusion Criteria
* Patient must be able to complete consent and hold mask
* Baseline room air oxygen saturation \<94% or new supplemental oxygen requirement at presentation or patient on supplemental oxygen at baseline and requiring up-titration of oxygen setting
* Patient in negative pressure room
* Patient must have access to an internet-connected device
Exclusion Criteria
* History of pneumothorax or known bullous lung disease
* Recent cataract surgery
* Patient receiving NIV (Noninvasive Ventilation) or HFNC (High Flow Nasal Cannula)
* Patient receiving mechanical ventilation
* Delirium
18 Years
ALL
No
Sponsors
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MEDEX
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Loretta Que, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Health System
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00105246
Identifier Type: -
Identifier Source: org_study_id
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