To evaluate the physiological effects, feasibility, tolerability and safety of CPAP via a face mask in patients with COVID-19 pneumonia requiring high inspired oxygen fractions during spontaneous breathing.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Pneumonia due to SARS-coronavirus 2 (SARS-Cov2, COVID-19) is characterised by
bilateral ground-glass opacities comparable with the radiological and clinical
characteristics that are often encountered in acute respiratory distress
syndrome (ARDS). Patients with COVID-19 pneumonia frequently require high
inspiratory oxygen concentrations to avoid hypoxemia. In contrast to ARDS, the
compliance of the respiratory system of patients with COVID-19 often remains
normal. Therefore, it is postulated that these patients benefit from moderate
positive end expiratory pressure (PEEP) to recruit lung tissue and to decrease
right-to-left shunt. PEEP can be delivered noninvasively as continuous positive
airway pressure (CPAP) via a face mask in conjunction with high inspiratory
oxygen fractions.
Study objective
To evaluate the physiological effects, feasibility, tolerability and safety of
CPAP via a face mask in patients with COVID-19 pneumonia requiring high
inspired oxygen fractions during spontaneous breathing.
Study design
Cross-over phase 1 intervention study. Patients are first monitored during
conventional oxygen support via a non-rebreathing mask (standard of care) and
are subsequently crossed over to an open-circuit face mask with CPAP 0 cmH2O
and the same face mask with CPAP 7.5 cmH2O. Each modality is applied for 30
minutes.
Intervention
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).
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 create PEEP).
2. Oxygen delivery via the face mask with zero PEEP in order to test the effect
of the mask alone.
3. Oxygen delivery via the face mask with PEEP of 7.5 cmH2O in order to test
effect of moderate PEEP.
Study burden and risks
Extent of the burden and risks:
1. Arterial puncture can be painful, in rare cases complications have been
described
2. Breathing through a face mask may be uncomfortable. Talking is more
difficult and eating and drinking is not possible while wearing the mask.
3. Some people have the tendency to become restless or panic while wearing a
mask (a variant of claustrophobia), which may provoke excessive ventilation
(hyperventilation).
4. The positive pressure in the mask may also be experienced as uncomfortable
5. Someone who does not breathe easily through the mask may develop
hypoventilation, which may aggravate hypoxaemia.
Benefit and group relatedness:
The burden for participation is the exchange of one face mask for another,
which might be more or may be less comfortable for the patient. Therefore, the
tolerability and safety of the device is also assessed as a secondary outcome
of the study. All measurements to obtain the study parameters can be obtained
non-invasively and do not impose any discomfort for the patient. The patient
can benefit from the treatment by maintaining CPAP therapy when well tolerated,
which may result in better oxygenation and less work of breathing. The whole
population of hospitalised Covid-19 patients might benefit from this treatment
if it is shown to improve oxygenation and respiratory rate as it may prevent
the need for intubation and invasive mechanical ventilation. Moreover, as
compared to other high flow oxygen devices, it prevents aerosol dispersion into
the environment due to the tubing system with an expiratory filter. The setup
can be managed relatively easily and can be produced in large quantities.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73770.018.20 |
| Other | NL8521 |