Clinical trial NCT05648097: Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19
Official title: Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: Sars-CoV2
Aerosols
Infection transmission
Infection risk
Respiratory Tract Infections
Virus Diseases
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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".

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnancy, unability to give consent (e.g. informed consent form not available in patient language or non-judicious)

Primary outcomes:
measure: Proportion of nosocomially infected individuals within 4 days after exposure
timeFrame: 4 days after last exposure
Secondary outcomes:
measure: Exposure duration
timeFrame: Period when exposed to a patient with confirmed COVID-19 in the same room
measure: Proportion of immunocompromised patients among those exposed
timeFrame: At the time of exposure
measure: Preexisting air change rate per hour in the rooms where exposure occurs
timeFrame: At the time of exposure
measure: Age of exposed patients
timeFrame: At the time of exposure
measure: Gender of exposed patients
timeFrame: At the time of exposure
measure: Proportion of nosocomially infected patients within 10 days after exposure
timeFrame: 10 days after last exposure
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern University Hospital
state: Canton Of Bern
Study officials:
affiliation: Department of Infectious Diseases Inselspital Bern University Hospital
name: Philipp Jent, MD
role: PRINCIPAL_INVESTIGATOR
References: