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Completed

NCT Number: NCT04770597

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda Hospital

Bonheiden, 2820, Belgium

About this study

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:

  • 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

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Double-bed hospital rooms

Exclusion criteria

  • Unoccupied rooms

Treatment and study plan

Aranet4 Home CO2 monitor

Device

The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Imelda Hospital, Bonheiden

Other

Registry information

Official study title

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

Acronym: MICH

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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