Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital

Healthcare Associated Infection Clinical Trial

— MICH  

Official title:

Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital: a Randomized, Sham-controlled, Open Label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770597
• Other study ID #: 20210209
• Status: Completed
• Phase: N/A
• Start date: February 21, 2021
• Est. completion date: May 2, 2021

Study information

• Verified date: May 2021
• Source: Imelda Hospital, Bonheiden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ventilation with fresh outdoor air has recently gained considerable attention as a means to reduce the potential risk of indoor aerosol transmission of respiratory pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing coronavirus disease 2019 (COVID-19). Commercial carbon dioxide (CO2) monitors are increasingly used in schools, long-term care facilities, offices and public buildings to monitor indoor ventilation. However, no formal evidence is available to support the effectiveness of feedback from CO2 monitoring devices. Moreover, modern hospitals have superior indoor air quality control systems.

The aim of this prospective pilot randomized controlled trial (RCT) is to evaluate whether CO2 monitoring devices would be useful as a means to further maintain lower indoor CO2 concentrations in hospitals.

Description:

In this pilot, randomized, sham-controlled open-label RCT, hospital rooms will be fitted with Aranet4 Home CO2 sensors.

Each device will continuously measure indoor CO2 concentrations at 1-minute intervals during 4 time periods:

1. Baseline: staff blinded to CO2 levels displayed on sensor

2-3. Sham/Intervention period: sensors on the same ward will be randomized to placebo (sensor not showing CO2 levels to staff) or Intervention (sensor displaying CO2 levels to staff) in a cross-over design

4. Post-intervention phase (3 weeks post-intervention): staff blinded to CO2 levels

Each measurement period will consist of 7 days with no washout period.

Our primary hypothesis is that CO2 sensors will record less time (minutes) with elevated CO2 levels during the intervention period, compared to the Sham periods. However, carry-over effects will be investigated by comparing the Intervention periods to the Baseline and Post-intervention phases.

Note [February 27, 2021]: due to technical problems with the Aranet4 device Bluetooth connection, outcome data will be analyzed according to measurement data at 2-5 minute intervals (measurements can be made every minute, but data cannot be downloaded with the current version of the app due to technical problems).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2, 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Double-bed hospital rooms

Exclusion Criteria:

• Unoccupied rooms

Related Conditions & MeSH terms

• Cross Infection
• Healthcare Associated Infection

Intervention

Device:
• Aranet4 Home CO2 monitor
The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden

Sponsors (1)

Lead Sponsor	Collaborator
Imelda Hospital, Bonheiden

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Staff-rated feasibility on a 10-point Likert scale [0-10, with 10 indicating better outcome]	How feasible is it to use CO2 sensors to monitor indoor air quality in hospital? Anonymous online survey during the post-intervention phase	7 days
Other	Staff-rated preference on a 10-point Likert scale [0-10, with 10 indicating better outcome]	Would you prefer to use CO2 sensors to monitor indoor air quality in hospital in the future? Anonymous online survey during the post-intervention phase	7 days
Primary	Time >800 ppm CO2	Time/day (in minutes/24h) measuring >800 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)
Secondary	Time >1000 ppm CO2	Time/day (in minutes/24h) measuring >1000 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)
Secondary	Time >1400 ppm CO2	Time/day (in minutes/24h) measuring >1400 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)
Secondary	Daily peak CO2 concentration [in ppm]	Daily peak CO2 concentration [in ppm]	7 days/time period (pre-, active/sham and post-intervention)