Continuous positive airway pressure in severe Covid-19 pneumonia

Conditions: Corona virus disease 2019 (Covid-19), proven with PCR on nasopharyngeal swab and with matching abnormalities on low-dose CT-scan

Registration Number: NL-OMON28307

Lead Sponsor: Raad van Bestuur van het AMC (Amsterdam)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 13

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

-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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A change in the two-dimensional variable (SpO2, RR), the combination of oxygen saturation and respiratory rate.<br>SpO2 is measured with a pulse oximeter and RR is derived from the pressure changes in the mouth compartment of the mask. <br>

Secondary Outcome Measures

Name	Time	Method
1.Patient satisfaction score and Borg dyspnoea scale <br>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). <br>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).<br>4.Circulation: heart rate <br>5.Adverse events: painscore, decubitus, CO2 rebreathing, choking, mask malfunction otherwise<br>