Several weeks of home monitoring of blood oxygen levels of patients with or at risk of cardiovascular disease with moderate to severe symptoms of (presumably) COVID-19 by pulse oximetry might benefit the patient by early detection of hypoxemia, an…
ID
Bron
Verkorte titel
Aandoening
Patients presenting to primary care with moderate to severe symptoms of COVID-19 (both SARS-CoV-2 positive and untested patients).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility defined as successful inclusion of 50 participants within 6 months
Achtergrond van het onderzoek
Patients with moderate to severe symptoms of (presumably) COVID-19 are monitored at home by their GP using teleconsultation. This leaves the GP with a situation in which he/she has to rely on patients' symptom presentation and subjective assessment of shortness of breath by telephone. It is however known that patients' condition can deteriorate considerably after 7-14 days of symptom onset. Such a deterioratation with corresponding low oxygen saturation levels does often not align with patients' symptoms. In particular patients with overweight, hypertension, diabetes and other cardiovascular risk factors and cardiovascular diseases are at increased risk of a more complicated disease course requiring hospitalisation and sometimes even ICU admission.
Several weeks of home monitoring of blood oxygen levels by pulse oximetry might benefit the patient by early detection of hypoxemia, an important indicator for hospitalisation. In the proposed pilot trial, we perform an early phase evaluation of this new intervention in primary care.
Doel van het onderzoek
Several weeks of home monitoring of blood oxygen levels of patients with or at risk of cardiovascular disease with moderate to severe symptoms of (presumably) COVID-19 by pulse oximetry might benefit the patient by early detection of hypoxemia, an important indicator for hospitalisation. In the proposed pilot trial, we perform an early phase evaluation of this new intervention in primary care.
Onderzoeksopzet
Patients will be followed for 45 days
Onderzoeksproduct en/of interventie
Three times daily (and if needed any additional) measurement of oxygen saturation and pulse rate with a pulse oximeter as added to usual (primary) care versus usual (primary) care.
Publiek
Dorien Zwart
088 75 681 81
d.zwart@umcutrecht.nl
Wetenschappelijk
Dorien Zwart
088 75 681 81
d.zwart@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) Age ≥40 years
2) Cardiovasculair risk profile or cardiovascular disease (overweight, hypertension, diabetes, smoking, coronary artery disease, previous myocardial infarction, heart failure)
3) Presumably COVID-19 (both SARS-CoV-2 positive and non-COVID-19 confirmed patients)
4) Moderate-severe symptoms
5) Mentally competent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) Severe illness requiring hospital admission
2) Patient does not want future hospitalisation
3) Known anemia
4) Inadequate mastery of the Dutch language
5) Not willing to sign informed consent
6) Not willing to adhere to study procedures
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL8954 |
Ander register | METC Utrecht : METC 20-638/D |