The aim is to investigate how effective the addition of several PEEP levels provided by regular CPAP is in patients with COVID-19 with moderate oxygenation problems.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate how effective the addition of several levels of CPAP on top of
high oxygen supplementation is on oxygenation, defined peripheral oxygen
saturation (SpO2).
Secondary outcome
To investigate how effective the addition of several levels of CPAP on top of
high oxygen supplementation is on
- work of breathing, measured with surface EMG and by measuring breathing
frequency. EMG mesaurements will be performed with the ExG measurement devoce
of ItoM, This device is not CE certified yet, but is extensively tested in
healthy persons and has no risks.
- gas exchange: SpO2/FiO2 ratio and transcutaneously measured PtCO2
- Patient dyspnea measured with a Borg scale.
- Patient comfort measured with a Borg scale.
Background summary
Currently, there are no evidence based pharmacological treatments for COVID-19.
Therefore, until now, the most important therapy for COVID-19 is supportive
care. The main stain is the provision of high oxygen levels, usually by oxygen
masks. Also, high flow oxygen might be beneficial, but viral spread is a
problem that is difficult to control with this open system therapy. When
patients develop severe lung disease, they are transmitted to the intensive
care unit (ICU) and ventilated invasively via an endotracheal tube with
moderate to high PEEP levels, high inspired oxygen fraction (FiO2) and usually
low (protective) pressure support levels.
Pathophysiologically, the addition of positive-end-expiratory pressure (PEEP)
to high FiO2 might be attractive, also in the phase of moderate to severe
hypoxemia at the general ward. This can be delivered with CPAP trough a face
mask. CPAP is tried already at large scale in other countries during the
COVID-19 epidemic, however without any evidence of its efficacy in this
disease.
Study objective
The aim is to investigate how effective the addition of several PEEP levels
provided by regular CPAP is in patients with COVID-19 with moderate oxygenation
problems.
Study design
The study is an interventional explorative pilot study comparing the effect of
20 minutes of oxygen via a non-rebreathing mask (NRM) with 20 minutes CPAP with
15 L O2/min with different PEEP levels (5, 10 and 15 cm H2O) in random order
with 15 minutes interruption periods on the oxygen supplementation on
oxygenation and work of breathing.
Intervention
Patients will receive CPAP with high FiO2. With CPAP a continuous airflow is
provided through a well-fitting face mask.
Study burden and risks
There is a huge need for non-invasive ventilatory support measures at the
general ward during the COVID-19 epidemic, as ICU capacity may become limited
and some patients are not being transferred to the ICU because of multiple
comorbidities or fragility. By providing an effective additional non-invasive
way to support the pulmonary condition of COVID-19 patients we may unload the
ICUs and give patients probably a better chance to overcome this disease
without ICU admission.
There are no risk known of CPAP. The duration of application is short, so
regular side effects with longer-term CPAP use as nasal pressure soars or
aerophagia are not expected. Patients may deteriorate with CPAP. However,
during the CPAP application one of the investigators will be present all the
time and patients can easily be switched to the NRM again. Also, there may be a
fear that CPAP may delay ICU admission which may be a disadvantage for the
patient. However, application periods are short, patients are very closely
monitored and deterioration will be pick-up immediately.
The measurements of oxygenation, transcutaneous PtCO2, heart frequency and
respiratory rate and diaphragm muscle activity are all non-invasive and without
any risk.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
- > 18 years of age
- proven COVID-19 positive disease
- being admitted to the hospital with oxygenation problems, needing oxygen *
6L/min
- Patients need to be able to read and understand the patient information
letter and sign informed consent.
Exclusion criteria
* Patients with severe comorbid pulmonary disease or other diseases leading to
hypercapnic respiratory failure
* * Patients in instable condition (hypotensive, cardiac failure/arrhythmia,
more than 1 organ failure, upper airway obstruction, very high work of
breathing (breathing frequency at rest persistently > 30 breaths/min)
* Unable to fit mask
* Patients who are vomiting
* Agitated, uncooperative patients
* Patients who are unable to protect their airway (for example swallowing
impairment)
* Patients with excessive secretions that cannot be managed adequately
* Patients with recent upper airway of upper gastro-intestinal surgery
* Patients with severe skin disease making attachment of the ExG skin
electrodes impossible
* Pregnant patients
* Patients not being able to read and understand the patient information
letter and sign 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 | NL73800.042.20 |
| Other | UMCG research register 202000266 |