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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Baldachin
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Inselspital Bern University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard of Care

Baldachin-Intervention

Arm Description

Patients exposed to a patient with COVID-19 isolated at the site - standard of care

Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Exposure duration
Expected to be on average hours up to a few days
Proportion of immunocompromised patients among those exposed
e.g. patients under treatment with steroids, chemotherapy
Preexisting air change rate per hour in the rooms where exposure occurs
Age of exposed patients
As part of the demographic characteristics
Gender of exposed patients
As part of the demographic characteristics
Proportion of nosocomially infected patients within 10 days after exposure
As documented in the electronic patient record

Full Information

First Posted
December 12, 2022
Last Updated
September 21, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT05648097
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Sars-CoV2, Aerosols, Infection transmission, Infection risk, Respiratory Tract Infections, Virus Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Patients exposed to a patient with COVID-19 isolated at the site - standard of care
Arm Title
Baldachin-Intervention
Arm Type
Active Comparator
Arm Description
Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin
Intervention Type
Device
Intervention Name(s)
Baldachin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of nosocomially infected individuals within 4 days after exposure
Description
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
Time Frame
4 days after last exposure
Secondary Outcome Measure Information:
Title
Exposure duration
Description
Expected to be on average hours up to a few days
Time Frame
Period when exposed to a patient with confirmed COVID-19 in the same room
Title
Proportion of immunocompromised patients among those exposed
Description
e.g. patients under treatment with steroids, chemotherapy
Time Frame
At the time of exposure
Title
Preexisting air change rate per hour in the rooms where exposure occurs
Time Frame
At the time of exposure
Title
Age of exposed patients
Description
As part of the demographic characteristics
Time Frame
At the time of exposure
Title
Gender of exposed patients
Description
As part of the demographic characteristics
Time Frame
At the time of exposure
Title
Proportion of nosocomially infected patients within 10 days after exposure
Description
As documented in the electronic patient record
Time Frame
10 days after last exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Jent, MD
Phone
+41 31 632 99 92
Email
philipp.jent@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Karin J Grimm, MD
Phone
+41 31 63 2 76 85
Email
KarinJanina.Grimm@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Jent, MD
Organizational Affiliation
Department of Infectious Diseases Inselspital Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inselspital Bern University Hospital
City
Bern
State/Province
Canton Of Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Jent, MD
Phone
+41 31 632 99 92
Email
philipp.jent@insel.ch
First Name & Middle Initial & Last Name & Degree
Karin J Grimm, MD
Phone
+41 31 63 2 76 85
Email
KarinJanina.Grimm@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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