Covid19 Clinical Trial
— AirFLO2Official title:
AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients With COVID-19
Verified date | April 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study 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).
Status | Terminated |
Enrollment | 11 |
Est. completion date | November 8, 2021 |
Est. primary completion date | November 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults =18 years of age with confirmed COVID-19 infection - 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: - Tracheostomy - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Health System | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | MEDEX |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygenation as Measured by P:F Ratio (PaO2:FiO2) | A higher P:F ratio value indicates better oxygenation. Range 20 to 500. | Baseline, 24 hours, 48 hours | |
Secondary | Subject Dyspnea Symptoms | Improved symptoms related to dyspnea as measured by the change in the Modified Medical Research Council (MMRC).. Range 0 to 4 with lower values being better. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | |
Secondary | Change in Participant Cough Symptoms as Measured by the Leicester Cough Questionnaire (LCQ) | The Leicester Cough Questionnaire (LCQ) questionnaire has a score range of 3-21, where a higher score indicates better quality of life. | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | |
Secondary | Change in Participant Respiratory Symptoms as Measured by the St George Respiratory Questionnaire (SGRC) | The St George Respiratory Questionnaire (SGRC) questionnaire has a score range of 0-100, where a higher score indicates worse quality of life. | baseline to up to six hours for device intervention participants; baseline to hospital discharge (up to 30 days) for all patients | |
Secondary | Number of Participants Transferred to High Flow Nasal Cannula (HFNC), Non-invasive Ventilation (NIV), or Invasive Ventilation | Reduce risk of respiratory deterioration as measured by change from baseline to end of hospitalization (discharge or patient death) to high flow nasal cannula (HFNC), non-invasive ventilation (NIV), or invasive ventilation. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | |
Secondary | Number of Participants Transferred to the ICU | Reduced intensive care unit (ICU) transfer risk occurring between baseline and end of hospitalization | baseline to end of hospitalization, (discharge from hospital or death, 1 - 30 days range) | |
Secondary | Number of Participants Requiring Intubation | Reduce risk for intubation requirement as measured by incidence of intubation occurring between baseline and end of hospitalization (discharge or death) | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | |
Secondary | Hospitalization Length of Stay in Days | Hospitalization length of stay as measured by length of hospitalization after the baseline timepoint. | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days range) | |
Secondary | Number of Participants Who Survived to Discharge | Patient survival to hospital discharge as measured by the participant status at the end of the hospitalization (discharge or death) | baseline to end of hospitalization (discharge from hospital or death, 1 - 30 days expected range) |
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