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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthcare Associated Infection
• Intervention / Treatment: Device: Aranet4 Home CO2 monitor

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Double-bed hospital rooms

Exclusion Criteria:

• Unoccupied rooms

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; CO2 values on sensor visible to staff	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.
SHAM_COMPARATOR: Sham control; CO2 values on sensor not visible to staff	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time >800 ppm CO2	Time/day (in minutes/24h) measuring >800 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time >1000 ppm CO2	Time/day (in minutes/24h) measuring >1000 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)
Time >1400 ppm CO2	Time/day (in minutes/24h) measuring >1400 ppm CO2	7 days/time period (pre-, active/sham and post-intervention)
Daily peak CO2 concentration [in ppm]	Daily peak CO2 concentration [in ppm]	7 days/time period (pre-, active/sham and post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Imelda Hospital, Bonheiden
• Investigators: Principal Investigator: Michaël R Laurent, MD PhD, Geriatrics Department, Imelda Hospital Bonheiden

Publications and helpful links

General Publications

• Laurent MR, Frans J. Monitors to improve indoor air carbon dioxide concentrations in the hospital: A randomized crossover trial. Sci Total Environ. 2022 Feb 1;806(Pt 3):151349. doi: 10.1016/j.scitotenv.2021.151349. Epub 2021 Oct 30.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 21, 2021
• Primary Completion (ACTUAL): May 2, 2021
• Study Completion (ACTUAL): May 2, 2021

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Carbon dioxide; Ventilation; Indoor air quality
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Iatrogenic Disease; Cross Infection
• Other Study ID Numbers: 20210209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The full set of sensor data will be made available to established investigators upon simple request.
• IPD Sharing Time Frame: Data will be available upon fulltext print publication in a peer-reviewed journal, for a duration of at least 10 years.
• IPD Sharing Access Criteria: Simple e-mail request to the corresponding author by an established scientific investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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