Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients (OxyJet-CPAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04681859|
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Hypoxemia||Device: High Flow Nasal Oxygen (HFNO) treatment Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Evaluation of a Low-cost CPAP Device for Hypoxemic COVID-19 Patients: A Pilot Study|
|Estimated Study Start Date :||April 2021|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
|Active Comparator: High Flow Nasal Oxygen (HFNO) treatment||
Device: High Flow Nasal Oxygen (HFNO) treatment
Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.
|Experimental: Continuous positive airway pressure (CPAP) therapy using OxyJet||
Device: Continuous Positive Airway Pressure (CPAP) therapy using OxyJet
Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.
- Number of ventilator-free days [ Time Frame: 10 days ]The total number of days the patient was able to avoid being placed under a mechanical ventilator.
- Recovery of the patient [ Time Frame: 30 days ]The event that the patient has recovered and released from the hospital within 30 days.
- Death or need of intubation [ Time Frame: 10 days ]The event that the patient dies or requires to be placed under a mechanical ventilator.
- Oxygen toxicity or other adverse events [ Time Frame: 10 days ]Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681859
|Contact: Dr. Taufiq Hasan, PhDemail@example.com|
|Dhaka Medical College|
|Dhaka, Bangladesh, 1000|
|Contact: Dr. Md. Khairul Islam, MBBS,MCPS,FCPS|
|Principal Investigator: Dr. Robed Amin, MBBS, FCPS|
|Sub-Investigator: Dr. Md. Khairul Islam, MBBS, FCPS, MCPS|
|Sub-Investigator: Dr. Forhad Uddin Hasan Chowdhury, MBBS, FCPS|
|Sub-Investigator: Dr. Md. Mohiuddin Sharif, MBBS, MPA|
|Principal Investigator:||Dr. Taufiq Hasan, PhD||Bangladesh University of Engineering and Technology|
|Principal Investigator:||Dr. Robed Amin, MBBS, FCPS||Dhaka Medical College|