Corona virus pneumonia Covid-19
Conditions
Interventions
Delivery of supplemental oxygen via the face mask with inlet for inspired
oxygen delivery and outlet with viral/bacterial filter and a PEEP valve that
keeps the system under pressure (7.5 cmH2O).
T
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years - Positive for Covid-19 (positive nasopharyngeal swab PCR for SARS corona virus 2, with matching abnormalitis on the low-dose CT scan). - 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 - Multi-organ failure - 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 |
|---|---|
| The primary endpoint of the study is a change in the combination of oxygen saturation (measured by pulse oximetry, SpO2) and respiratory rate. The use of this combination of variables is substantiated by a recent study showing that the ratio of SpO2 divided by FIO2 (mean inspiratory O2 fraction) and RR are predictors of failure on high flow oxygen therapy. The combination of SpO2 and RR is important as a patient may respond positively through either an improvement of oxygenation (improved ventilation-perfusion matching in the lung or diminished diffusion disorder) or a reduction in respiratory rate. | — |
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). 4. Respiration: minimal negative pressure in the mouth compartment during inspiration (as a measure of inspiratory work of breathing), tidal volume, end-tidal and mixed-expiratory PO2 and PCO2 (as measures of pulmonary gas exchange). 5. Circulation: heart rate, rhythm ECG, continuous finger blood pressure (noninvasive) 6. Neurology: EMV scores 7. Adverse events: painscore, decubitus, CO2 rebreathing, choking, mask malfunction otherwise | — |
Countries
Netherlands
Outcome results
None listed