Physiological effect of the addition of CPAP on top of optimal oxygen supplementation on oxygenation and work of breathing in COVID-19 patients

Withdrawn

Conditions: Corona virus
SARS-CoV-2
10024970

Registration Number: NL-OMON49098

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate how effective the addition of several levels of CPAP on top of<br /><br>high oxygen supplementation is on oxygenation, defined peripheral oxygen<br /><br>saturation (SpO2). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To investigate how effective the addition of several levels of CPAP on top of<br /><br>high oxygen supplementation is on<br /><br>- work of breathing, measured with surface EMG and by measuring breathing<br /><br>frequency. EMG mesaurements will be performed with the ExG measurement devoce<br /><br>of ItoM, This device is not CE certified yet, but is extensively tested in<br /><br>healthy persons and has no risks.<br /><br>- gas exchange: SpO2/FiO2 ratio and transcutaneously measured PtCO2<br /><br>- Patient dyspnea measured with a Borg scale.<br /><br>- Patient comfort measured with a Borg scale.<br /><br></p><br>