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

• ClinicalTrials.gov Identifier: NCT04770597
• Recruitment Status: Completed
• First Posted: February 25, 2021
• Last Update Posted: May 11, 2021
• Sponsor: Imelda Hospital, Bonheiden
• Information provided by (Responsible Party): Michaël R Laurent, MD PhD, Imelda Hospital, Bonheiden

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthcare Associated Infection	Device: Aranet4 Home CO2 monitor	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Each sensor will be randomized to Sham-Intervention or Intervention-Sham cross-over. Additionally, each sensor will measure CO2 during a baseline and post-intervention phase.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital: a Randomized, Sham-controlled, Open Label Trial
• Actual Study Start Date: February 21, 2021
• Actual Primary Completion Date: May 2, 2021
• Actual Study Completion Date: May 2, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Time >800 ppm CO2 [ Time Frame: 7 days/time period (pre-, active/sham and post-intervention) ]
   Time/day (in minutes/24h) measuring >800 ppm CO2

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Staff-rated feasibility on a 10-point Likert scale [0-10, with 10 indicating better outcome] [ Time Frame: 7 days ]
   How feasible is it to use CO2 sensors to monitor indoor air quality in hospital? Anonymous online survey during the post-intervention phase
2. Staff-rated preference on a 10-point Likert scale [0-10, with 10 indicating better outcome] [ Time Frame: 7 days ]
   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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: When applicable, patients stay in double-bed rooms based on gender.
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Double-bed hospital rooms

Exclusion Criteria:

• Unoccupied rooms

Contacts and Locations

Locations

Belgium

Imelda Hospital

Bonheiden, Belgium, 2820

Sponsors and Collaborators

Imelda Hospital, Bonheiden

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Michaël R Laurent, MD PhD, Principal Investigator, Imelda Hospital, Bonheiden
• ClinicalTrials.gov Identifier: NCT04770597
• Other Study ID Numbers: 20210209
• First Posted: February 25, 2021
• Last Update Posted: May 11, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The full set of sensor data will be made available to established investigators upon simple request.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: Data will be available upon fulltext print publication in a peer-reviewed journal, for a duration of at least 10 years.
• Access Criteria: Simple e-mail request to the corresponding author by an established scientific investigator

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michaël R Laurent, MD PhD, Imelda Hospital, Bonheiden:

Indoor air quality; Carbon dioxide; Ventilation

Additional relevant MeSH terms:

Cross Infection; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes