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

Primary Purpose

Healthcare Associated Infection

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Aranet4 Home CO2 monitor
Sponsored by
Imelda Hospital, Bonheiden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthcare Associated Infection focused on measuring Indoor air quality, Carbon dioxide, Ventilation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Double-bed hospital rooms

Exclusion Criteria:

  • Unoccupied rooms

Sites / Locations

  • Imelda Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention

Sham control

Arm Description

CO2 values on sensor visible to staff

CO2 values on sensor not visible to staff

Outcomes

Primary Outcome Measures

Time >800 ppm CO2
Time/day (in minutes/24h) measuring >800 ppm CO2

Secondary Outcome Measures

Time >1000 ppm CO2
Time/day (in minutes/24h) measuring >1000 ppm CO2
Time >1400 ppm CO2
Time/day (in minutes/24h) measuring >1400 ppm CO2
Daily peak CO2 concentration [in ppm]
Daily peak CO2 concentration [in ppm]

Full Information

First Posted
February 16, 2021
Last Updated
May 7, 2021
Sponsor
Imelda Hospital, Bonheiden
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1. Study Identification

Unique Protocol Identification Number
NCT04770597
Brief Title
Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital
Acronym
MICH
Official Title
Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital: a Randomized, Sham-controlled, Open Label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 21, 2021 (Actual)
Primary Completion Date
May 2, 2021 (Actual)
Study Completion Date
May 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imelda Hospital, Bonheiden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infection
Keywords
Indoor air quality, Carbon dioxide, Ventilation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
CO2 values on sensor visible to staff
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
CO2 values on sensor not visible to staff
Intervention Type
Device
Intervention Name(s)
Aranet4 Home CO2 monitor
Intervention Description
The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.
Primary Outcome Measure Information:
Title
Time >800 ppm CO2
Description
Time/day (in minutes/24h) measuring >800 ppm CO2
Time Frame
7 days/time period (pre-, active/sham and post-intervention)
Secondary Outcome Measure Information:
Title
Time >1000 ppm CO2
Description
Time/day (in minutes/24h) measuring >1000 ppm CO2
Time Frame
7 days/time period (pre-, active/sham and post-intervention)
Title
Time >1400 ppm CO2
Description
Time/day (in minutes/24h) measuring >1400 ppm CO2
Time Frame
7 days/time period (pre-, active/sham and post-intervention)
Title
Daily peak CO2 concentration [in ppm]
Description
Daily peak CO2 concentration [in ppm]
Time Frame
7 days/time period (pre-, active/sham and post-intervention)
Other Pre-specified Outcome Measures:
Title
Staff-rated feasibility on a 10-point Likert scale [0-10, with 10 indicating better outcome]
Description
How feasible is it to use CO2 sensors to monitor indoor air quality in hospital? Anonymous online survey during the post-intervention phase
Time Frame
7 days
Title
Staff-rated preference on a 10-point Likert scale [0-10, with 10 indicating better outcome]
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
When applicable, patients stay in double-bed rooms based on gender.
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Double-bed hospital rooms Exclusion Criteria: Unoccupied rooms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michaël R Laurent, MD PhD
Organizational Affiliation
Geriatrics Department, Imelda Hospital Bonheiden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The full set of sensor data will be made available to established investigators upon simple request.
IPD Sharing Time Frame
Data will be available upon fulltext print publication in a peer-reviewed journal, for a duration of at least 10 years.
IPD Sharing Access Criteria
Simple e-mail request to the corresponding author by an established scientific investigator
Citations:
PubMed Identifier
34728206
Citation
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.
Results Reference
derived

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

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