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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Healthcare Associated Infection

Intervention / Treatment
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* Device: Aranet4 Home CO2 monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Double-bed hospital rooms Exclusion Criteria: Unoccupied rooms
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>CO2 values on sensor visible to staff | Device: Aranet4 Home CO2 monitor<br>* The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.<br>|
| Sham Comparator: Sham control<br>CO2 values on sensor not visible to staff | Device: Aranet4 Home CO2 monitor<br>* The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indoor air quality, Carbon dioxide, Ventilation