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

Not Applicable

Completed

• Conditions: Healthcare Associated Infection
• Interventions: Device: Aranet4 Home CO2 monitor

• Registration Number: NCT04770597
• Lead Sponsor: Imelda Hospital, Bonheiden

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.

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 Timeline

• Study First Submitted: 2021-02-16
• Study Start: 2021-02-21
• Study First Submitted QC: 2021-02-21
• Study First Posted: 2021-02-25
• Status Verified: 2021-05
• Primary Completion: 2021-05-02
• Study Completion: 2021-05-02
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Double-bed hospital rooms

Exclusion Criteria

• Unoccupied rooms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Aranet4 Home CO2 monitor	CO2 values on sensor visible to staff
Sham control	Aranet4 Home CO2 monitor	CO2 values on sensor not visible to staff

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Imelda Hospital; 🇧🇪 Bonheiden, Belgium