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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05648097
• Other study ID #: Balda01
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Philipp Jent, MD
• Phone: +41 31 632 99 92
• Email: philipp.jent[@]insel.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Baldachin
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.

Locations

Country	Name	City	State
Switzerland	Inselspital Bern University Hospital	Bern	Canton Of Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of nosocomially infected individuals within 4 days after 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	4 days after last exposure
Secondary	Exposure duration	Expected to be on average hours up to a few days	Period when exposed to a patient with confirmed COVID-19 in the same room
Secondary	Proportion of immunocompromised patients among those exposed	e.g. patients under treatment with steroids, chemotherapy	At the time of exposure
Secondary	Preexisting air change rate per hour in the rooms where exposure occurs		At the time of exposure
Secondary	Age of exposed patients	As part of the demographic characteristics	At the time of exposure
Secondary	Gender of exposed patients	As part of the demographic characteristics	At the time of exposure
Secondary	Proportion of nosocomially infected patients within 10 days after exposure	As documented in the electronic patient record	10 days after last exposure