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Evaluation of a Low-cost CPAP Device on Hospitalized COVID-19 Patients (OxyJet-CPAP)

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ClinicalTrials.gov Identifier: NCT04681859
Recruitment Status : Not yet recruiting
First Posted : December 23, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
Dhaka Medical College
Information provided by (Responsible Party):
Bangladesh University of Engineering and Technology

Brief Summary:
The aim of this study is to evaluate the preliminary safety and performance of a low-cost locally-made Venturi-based Non-invasive Positive Pressure Ventilator (NIPPV) device for hypoxemic COVID-19 patients. The device administers Continuous Positive Airway Pressure (CPAP) therapy using the jet-mixing or Venturi effect to increase the volume flow rate of oxygenated air from a pressurized cylinder by entraining the atmospheric air. To provide CPAP therapy, this high flow of oxygenated air is delivered to the patient via a low-cost non-vented mask with a tight seal with a High-Efficiency Particulate Air (HEPA) filter connected to the exhalation limb. The tight seal and HEPA filter ensures a minimal risk of aerosol generation and thus the device can be used without a negative pressure room. The system consists of the developed Venturi-based flow-generator, a standard 22mm breathing tube, a standard Y-connector, a non-vented CPAP mask (e.g., snorkel mask, helmet), a HEPA filter, and a Positive End Expiratory Pressure (PEEP) valve. The bench-top testing of the device is done in the laboratories of BUET and was verified that the device performs within the CPAP guidelines provided by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. This study aims to assess the safety of and efficacy of the device in three different steps: (1) design validation, (2) clinical feasibility and (3) pilot clinical trial for safety and efficacy evaluation. Only if the device successfully passes the parts 1 and 2, the investigators will proceed to the final clinical trial in step 3. In this final step, the investigators aim to conduct a randomized controlled trial (RCT) evaluating for non-inferiority of the CPAP intervention compared to standard HFNO treatment. The number of ventilator-free days will be used as the primary outcome for efficacy, while patient recovery, death, or need of intubation and other adverse events will be used as secondary outcomes.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Recovery of the patient [ Time Frame: 30 days ]
    The event that the patient has recovered and released from the hospital within 30 days.

  2. Death or need of intubation [ Time Frame: 10 days ]
    The event that the patient dies or requires to be placed under a mechanical ventilator.

  3. Oxygen toxicity or other adverse events [ Time Frame: 10 days ]
    Oxygen toxicity or other adverse event rating according to the CTCAE scale (1-5)



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed or suspected COVID-19 patient (by RT-PCR) having severe pneumonia and hypoxemia (SpO2 ≤90%) who did not respond to standard oxygen therapy (non-rebreather mask on 15L/min at 100% FiO2).

Exclusion Criteria:

  • Severely hypoxemic patients (SpO2≤85%)
  • Patients with low respiratory drive or requiring cardiopulmonary resuscitation
  • Patients with contraindications for CPAP
  • Pregnant status
  • Age > 60 years

Information from the National Library of Medicine

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


Contacts
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Contact: Dr. Taufiq Hasan, PhD +8801817579844 taufiq@bme.buet.ac.bd

Locations
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Bangladesh
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         
Sponsors and Collaborators
Bangladesh University of Engineering and Technology
Dhaka Medical College
Investigators
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Principal Investigator: Dr. Taufiq Hasan, PhD Bangladesh University of Engineering and Technology
Principal Investigator: Dr. Robed Amin, MBBS, FCPS Dhaka Medical College
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Responsible Party: Bangladesh University of Engineering and Technology
ClinicalTrials.gov Identifier: NCT04681859    
Other Study ID Numbers: BME-BUET-003
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory