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Baldachin: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19

Baldachin-Study: Ceiling HEPA-filtration to Prevent Nosocomial Transmission of COVID-19 in Open-space Multiple Bed Patient Areas

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05648097
Enrollment
104
Registered
2022-12-13
Start date
2023-09-13
Completion date
2024-11-30
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases

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.

Interventions

DEVICEBaldachin

Environmental intervention: Equipment of a patient space of a patient with confirmed COVID-19 in open-space multiple bed Intermediate Care Unit areas with a mobile, optimally placed high efficiency particulate air (HEPA)-equivalent air filtration unit (Baldachin) in addition to existing room ventilation and hospital policy infection prevention and control measures.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Proportion of nosocomially infected individuals within 4 days after exposure4 days after last exposureAssessed 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

MeasureTime frameDescription
Proportion of immunocompromised patients among those exposedAt the time of exposuree.g. patients under treatment with steroids, chemotherapy
Preexisting air change rate per hour in the rooms where exposure occursAt the time of exposure
Exposure durationPeriod when exposed to a patient with confirmed COVID-19 in the same roomExpected to be on average hours up to a few days
Gender of exposed patientsAt the time of exposureAs part of the demographic characteristics
Proportion of nosocomially infected patients within 10 days after exposure10 days after last exposureAs documented in the electronic patient record
Age of exposed patientsAt the time of exposureAs part of the demographic characteristics

Countries

Switzerland

Contacts

Primary ContactPhilipp Jent, MD
philipp.jent@insel.ch+41 31 632 99 92
Backup ContactKarin J Grimm, MD
KarinJanina.Grimm@insel.ch+41 31 63 2 76 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026