COVID, Acute Hypoxemic Respiratory Failure
Conditions
Brief summary
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.
Detailed description
A detailed description can be found in the study protocol published in Trials in Dec 2020: Tverring, J., Åkesson, A. & Nielsen, N. Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET). Trials 21, 994 (2020). https://doi.org/10.1186/s13063-020-04863-5
Interventions
DEVICEHelmet CPAP
Start-up air flow 40 L/min. Start-up PEEP 5 cmH2O. Max PEEP 20 cmH2O. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
DEVICEHFNC
Start-up air flow 30 L/min. Max air flow 60 L/min. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
Sponsors
Region Skane
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Free Days (VFD) | 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SpO2/FiO2-ratio | 1 hour after randomisation | Peripheral oxygen saturation divided by fraction of inspired oxygen |
| Patient comfort | 24 hours after randomisation | Visual scale (1-10) |
| Frequency of endotracheal intubation | 28 days | Min 0, Max 1 |
| Frequency of carbon dioxide rebreathing | 28 days | Defined as pCO2 \> 6 kPa in a venous blood gas. Min 0, Max ∞ |
| Days alive within | 28 days and 180 days | All-cause mortality. (180 days endpoint not in primary publication) |
Countries
Sweden
Outcome results
None listed