Continuous positive airway pressure in severe Covid-19 pneumonia: a feasibility and physiological end-point study

Recruiting

Conditions: Corona virus pneumonia
Covid-19
10024970

Registration Number: NL-OMON49805

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 13

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is a change in the combination of oxygen<br /><br>saturation (measured by pulse oximetry, SpO2) and respiratory rate. The use of<br /><br>this combination of variables is substantiated by a recent study showing that<br /><br>the ratio of SpO2 divided by FIO2 (mean inspiratory O2 fraction) and RR are<br /><br>predictors of failure on high flow oxygen therapy. The combination of SpO2 and<br /><br>RR is important as a patient may respond positively through either an<br /><br>improvement of oxygenation (improved ventilation-perfusion matching in the lung<br /><br>or diminished diffusion disorder) or a reduction in respiratory rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Patient satisfaction score and Borg dyspnoea scale<br /><br>2. System performance: Stability of O2 delivery and CO2 build-up in the mask<br /><br>during the 30-min recording time (measured as the mean inspiratory PO2 and<br /><br>PCO2, respectively).<br /><br>4. Respiration: minimal negative pressure in the mouth compartment during<br /><br>inspiration (as a measure of inspiratory work of breathing), tidal volume,<br /><br>end-tidal and mixed-expiratory PO2 and PCO2 (as measures of pulmonary gas<br /><br>exchange).<br /><br>5. Circulation: heart rate, rhythm ECG, continuous finger blood pressure<br /><br>(noninvasive)<br /><br>6. Neurology: EMV scores<br /><br>7. Adverse events: painscore, decubitus, CO2 rebreathing, choking, mask<br /><br>malfunction otherwise</p><br>