COVID Clinical Trial
— COVID HELMETOfficial title:
Helmet Continuous Positive Airway Pressure Versus High-Flow Nasal Cannula in COVID-19: A Pragmatic Randomised Clinical Trial
Verified date | April 2021 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We aim to investigate whether the use of Continuous Positive Airway Pressure using a Helmet device (Helmet CPAP) will increase the number of days alive and free of ventilator within 28 days compared to the use of a High Flow Nasal Cannula (HFNC) in patients admitted to Helsingborg Hospital, Sweden, suffering from COVID-19 and an acute hypoxic respiratory failure.
Status | Terminated |
Enrollment | 2 |
Est. completion date | April 12, 2021 |
Est. primary completion date | April 12, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (all of the following): 1. Age = 18 years 2. Sars-Cov-2 found in the upper or lower respiratory tract by PCR during the current disease episode 3. Peripheral oxygen saturation (SpO2) < 92 % despite conventional low-flow oxygen therapy of at least 6 L /min for at least 15 min 4. A decision to initiate HFNC or Helmet CPAP by the attending ward physician 5. The patient has given written informed consent to participate. Exclusion Criteria (any of the following): 1. Need for direct admission to the intensive care unit for mechanical ventilation 2. Unconsciousness or drowsiness 3. Pneumothorax 4. Carbon dioxide pressure (pCO2) > 6 kPa in venous blood gas (VBG) 5. Underlying chronic obstructive pulmonary disease stage III-IV 6. A decision not to participate 7. Inability to comprehend the study content and give informed consent |
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg's Hospital | Helsingborg | Region Skane |
Lead Sponsor | Collaborator |
---|---|
Lund University | Region Skane |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ventilator-Free Days (VFD) | Number of days alive and free of mechanical ventilation within 28 days. Patients who die within 28 days will be counted as 0 VFD. Time in ventilator will be counted in hours and rounded to whole days. | 28 days | |
Secondary | SpO2/FiO2-ratio | Peripheral oxygen saturation divided by fraction of inspired oxygen | 1 hour after randomisation | |
Secondary | Patient comfort | Visual scale (1-10) | 24 hours after randomisation | |
Secondary | Frequency of endotracheal intubation | Min 0, Max 1 | 28 days | |
Secondary | Frequency of carbon dioxide rebreathing | Defined as pCO2 > 6 kPa in a venous blood gas. Min 0, Max 8 | 28 days | |
Secondary | Days alive within | All-cause mortality. (180 days endpoint not in primary publication) | 28 days and 180 days |
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