Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19
- Conditions
- COVID-19
- Interventions
- Device: Baldachin
- Registration Number
- NCT05648097
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
In this study, a patient space occupied by a patient with confirmed COVID-19 in an open-space multiple bed area in the Intermediate Care Unit will be equipped with a mobile, optimally placed high efficiency particulate air ("HEPA")-equivalent air filtration unit ("Baldachin") in addition to existing hospital policy infection prevention and control measures. The investigators are going to evaluate this intervention regarding its capacity to prevent the nosocomial onwards transmission of Sars-COV2 to patients located in the same multiple-bed open space patient area.
- Detailed Description
SARS-CoV-2 transmission includes a considerable amount of long-distance aerosol transmission. Ideal isolation is in single rooms. Isolation in special care multiple bed open-space patient areas (e.g. in the Intensive and Intermediate Care Unit) is set back to onsite isolation with distancing and ventilation as partial mitigation measures against nosocomial transmission.
The investigators want to assess the effect of supplementation of existing room ventilation by means of an optimally placed mobile high efficiency particulate air ("HEPA") filtration unit ("Baldachin") in the ceiling area over confirmed COVID-19 infected patients on nosocomial onwards transmission to patients located in the same open-space multiple bed area. In order to quantify the effect, the investigators will determine the proportion of nosocomially infected individuals as assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit rooms with "Baldachin" vs. open-space Intermediate Care Unit rooms without "Baldachin".
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
- Adult inpatients of included open-space IMC units with lab-confirmed SARS-CoV-2 infection, symptom onset or date of test ≤10 days prior inclusion.
- Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baldachin-Intervention Baldachin Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin
- Primary Outcome Measures
Name Time Method Proportion of nosocomially infected individuals within 4 days after exposure 4 days after last exposure Assessed by nasopharyngeal swab on day 4 after the last exposure amongst all in the same room exposed patients in cardiovascular open-space Intermediate Care Unit ("IMC") rooms with the environmental interventions vs. open-space IMC rooms without the environmental intervention
- Secondary Outcome Measures
Name Time Method Proportion of immunocompromised patients among those exposed At the time of exposure e.g. patients under treatment with steroids, chemotherapy
Proportion of nosocomially infected patients within 10 days after exposure 10 days after last exposure As documented in the electronic patient record
Age of exposed patients At the time of exposure As part of the demographic characteristics
Gender of exposed patients At the time of exposure As part of the demographic characteristics
Exposure duration Period when exposed to a patient with confirmed COVID-19 in the same room Expected to be on average hours up to a few days
Preexisting air change rate per hour in the rooms where exposure occurs At the time of exposure
Trial Locations
- Locations (1)
Inselspital Bern University Hospital
🇨🇭Bern, Canton Of Bern, Switzerland