Corona virus disease 2019 (Covid-19), proven with PCR on nasopharyngeal swab and with matching abnormalities on low-dose CT-scan
Conditions
Interventions
Three conditions are tested (each lasting 30 min, the ‘measurement period’):
1. Oxygen delivery via a nonrebreathing mask (current standard of care) with sufficient inflow of O2 (which does not creat
Sponsors
Raad van Bestuur van het AMC (Amsterdam)
Eligibility
Inclusion criteria
Inclusion criteria: A subject must meet all of the following criteria: - age > 18 years - Positive for Covid-19 (CORADS 5, i.e. highly likely Covid-19 on the low-dose CT scan, or PCR positive nasopharyngeal swab for SARS Coronavirus 2). - Admitted to Amsterdam UMC, location AMC. - A transcutaneous O2 saturation (SpO2) of 90% or less at 5 l/min oxygen administration via nasal canula. - Provide informed consent.
Exclusion criteria
Exclusion criteria: - Hypercapnia (defined as arterial PCO2 > 6.0 kPa or 45 mmHg) - A history of moderate to severe Chronic Obstructive Pulmonary Disease (COPD, GOLD severity III or IV), restrictive lung disease, or Obesity Hypoventilation Syndrome - Need for intubation or admission to the Intensive Care Unit as determined by the responsible physician - Palliative care - Reduced consciousness - Vomiting - Unability to wear the mask due to anatomical / physical restriction (e.g. facial operations; bearded) - Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in the two-dimensional variable (SpO2, RR), the combination of oxygen saturation and respiratory rate. SpO2 is measured with a pulse oximeter and RR is derived from the pressure changes in the mouth compartment of the mask. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction score and Borg dyspnoea scale 2. System performance: Stability of O2 delivery and CO2 build-up in the mask during the 30-min recording time (measured as the mean inspiratory PO2 and PCO2, respectively). 3. Respiration: tidal volume, minimal negative pressure in the mouth compartment during inspiration (as a measure of inspiratory work of breathing), end-tidal and mixed-expiratory PO2 and PCO2 (as measures of pulmonary gas exchange). 4. Circulation: heart rate 5. Adverse events: painscore, decubitus, CO2 rebreathing, choking, mask malfunction otherwise | — |
Contacts
Public ContactJoost van den Aardweg
Amsterdam UMC, location AMC
Outcome results
None listed