- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04334252
Descriptive Study Regarding Ambulant Screening During COVID-19 Pandemia
Descriptive Study Regarding the Ambulant Screening Protocol for COVID-19 in Times of High SARS CoV-2 Prevalence
Studieöversikt
Detaljerad beskrivning
The exact prevalence of COVID-19 is unknown. Due to the relatively high number of diagnosed, symptomatic infections despite a strict policy, we expect a high prevalence of COVID 19 throughout the entire population. The risk that an asymptomatic carrier who is admitted to the hospital for a (semi)urgent surgery, treatment of investigation transfers the virus to the hospital staff is very high, and vice versa. This risk is even higher during surgery, where intubation is necessary. Therefore we would like to pre-screen all patients ambulantly on the presence of COVID 19 since there is no consensus for screening at the moment. The golden standard is the SARS CoV-2 PCR on the nasopharyngeal sample together with a CT scan of the lungs. Patients in which a bloodsample is taken as standard of care procedure in this ambulant screening will be asked to give more blood for further investigation.
On top of this standard of care screening, we will perform a questionnaire at the pre-operative visit which evaluates the possible occurence of certain symptoms in the last 2 weeks. These symptoms are fever, anorexia, cough, diarrhea, sneezing, vomiting, dyspnea, headache, rhinorrhea, loss of smell, muscle pain, sputum, sore throat and fatigue. Patients were also asked if one of their housemates are affected by these symptoms. Furthermore, 2 weeks after surgery, patient will be contacted to phone in order to fill the same questionnaire.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Hasselt, Belgien, 3500
- Jessa Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- All adult patients > 18 years scheduled for a (semi) urgent surgery, hematological or oncological treatment or elektrophysiciological investigations in the Jessa hospital
Exclusion Criteria:
- Patients < 18 years
- Adult patients who are unable the give informed consent
- Language barrier
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prevalence of symptoms
Tidsram: at the ambulant screening
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Prevalence of fever, cough, anorexia, fatigue, diarrhea, vomiting, dyspnee, sore throat and sputum
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at the ambulant screening
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Prevalence of positive Sars CoV-2 PCR
Tidsram: at the ambulant screening
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Prevalence of positive COVID 19 tests in patients planned for surgery, treatment or investigation in the hospital
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at the ambulant screening
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Prevalence of positive radiological findings
Tidsram: at the ambulant screening
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Prevalence of positive radiological findings in CT scans of the lungs of planned for surgery, treatment or investigation in the hospital
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at the ambulant screening
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Prediction of symptoms
Tidsram: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on evaluated baseline questionnaire
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2 weeks after surgery or treatment
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Prediction of symptoms
Tidsram: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on radiological findings of CT scans
|
2 weeks after surgery or treatment
|
Prediction of symptoms
Tidsram: 2 weeks after surgery or treatment
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Prediction of symptoms of COVID 19, based on COVID 19 PCR results
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2 weeks after surgery or treatment
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- JessaH_COVID19_prescreening
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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