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

Sponsor
Imelda Hospital, Bonheiden (Other)
Overall Status
Completed
CT.gov ID
NCT04770597
Collaborator
(none)
12
1
2
2.3
5.2

Study Details

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
  • Device: Aranet4 Home CO2 monitor
N/A

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

  1. 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
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.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 :
Feb 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 [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 [7 days/time period (pre-, active/sham and post-intervention)]

    Time/day (in minutes/24h) measuring >1000 ppm CO2

  2. Time >1400 ppm CO2 [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] [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] [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] [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

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Double-bed hospital rooms
Exclusion Criteria:
  • Unoccupied rooms

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imelda Hospital Bonheiden Belgium 2820

Sponsors and Collaborators

  • Imelda Hospital, Bonheiden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michaël R Laurent, MD PhD, Principal Investigator, Imelda Hospital, Bonheiden
ClinicalTrials.gov Identifier:
NCT04770597
Other Study ID Numbers:
  • 20210209
First Posted:
Feb 25, 2021
Last Update Posted:
May 11, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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, Principal Investigator, Imelda Hospital, Bonheiden
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2021