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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Baldachin

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".

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philipp Jent, MD; Phone Number: +41 31 632 99 92; Email: philipp.jent@insel.ch
• Study Contact Backup: Name: Karin J Grimm, MD; Phone Number: +41 31 63 2 76 85; Email: KarinJanina.Grimm@insel.ch

Study Locations

• Switzerland
  • Canton Of Bern
    • Bern, Canton Of Bern, Switzerland, 3010
      • Recruiting
      • Inselspital Bern University Hospital
      • Contact: Philipp Jent, MD; Phone Number: +41 31 632 99 92; Email: philipp.jent@insel.ch
      • Contact: Karin J Grimm, MD; Phone Number: +41 31 63 2 76 85; Email: KarinJanina.Grimm@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 116 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Patients exposed to a patient with COVID-19 isolated at the site - standard of care
Active Comparator: Baldachin-Intervention; Patients exposed to a patient with COVID-19 isolated at the site - under Baldachin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of immunocompromised patients among those exposed	e.g. patients under treatment with steroids, chemotherapy	At the time of exposure
Preexisting air change rate per hour in the rooms where exposure occurs		At the time of exposure
Proportion of nosocomially infected patients within 10 days after exposure	As documented in the electronic patient record	10 days after last exposure
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
Age of exposed patients	As part of the demographic characteristics	At the time of exposure
Gender of exposed patients	As part of the demographic characteristics	At the time of exposure

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Philipp Jent, MD, Department of Infectious Diseases Inselspital Bern University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 13, 2022

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Virus Diseases; Respiratory Tract Infections; Aerosols; Sars-CoV2; Infection transmission; Infection risk
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Balda01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No