Healthcare Associated InfectionMICHNCT04770597
Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital
A study testing Aranet4 Home CO2 monitor in people with Healthcare Associated Infection, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthcare Associated Infection
- What is being tested?
- Aranet4 Home CO2 monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Feb 2021to 2 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Double-bed hospital rooms
Who cannot join
- Unoccupied rooms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital: a Randomized, Sham-controlled, Open Label Trial
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.
Read the 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:
- 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).
- Conditions
- Healthcare Associated Infection
- Being tested
- Aranet4 Home CO2 monitor
- Keywords
- Indoor air quality, Carbon dioxide, Ventilation
- Medical subject headings
- Cross Infection, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aranet4 Home CO2 monitorDevice
The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | CO2 values on sensor visible to staff Receives: Device: Aranet4 Home CO2 monitor |
| Sham control | Sham comparator | CO2 values on sensor not visible to staff Receives: Device: Aranet4 Home CO2 monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time >800 ppm CO2
Time/day (in minutes/24h) measuring >800 ppm CO2
Measured: 7 days/time period (pre-, active/sham and post-intervention)
Secondary outcomes (3)
Time >1000 ppm CO2
Time/day (in minutes/24h) measuring >1000 ppm CO2
Measured: 7 days/time period (pre-, active/sham and post-intervention)
Time >1400 ppm CO2
Time/day (in minutes/24h) measuring >1400 ppm CO2
Measured: 7 days/time period (pre-, active/sham and post-intervention)
Daily peak CO2 concentration [in ppm]
Daily peak CO2 concentration [in ppm]
Measured: 7 days/time period (pre-, active/sham and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start21 Feb 2021
- Primary completion2 May 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imelda Hospital, Bonheiden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaël R Laurent, MD PhD, Imelda Hospital, Bonheiden
- Investigators
- Michaël R Laurent, MD PhD, Principal investigator, Geriatrics Department, Imelda Hospital Bonheiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770597
- Sponsor's protocol ID
- 20210209
- Acronym
- MICH
- Status last verified
- May 2021
- First submitted
- 16 Feb 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full set of sensor data will be made available to established investigators upon simple request.
Publications
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.
PubMed 34728206
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitors to Improve Indoor Carbon Dioxide (CO2) Concentrations in the Hospital: a Randomized, Sham-controlled, Open Label Trial
- ClinicalTrials.gov ID
- NCT04770597
- Acronym / sponsor ID
- MICH / 20210209
- Conditions
- Healthcare Associated Infection
- Keywords
- Indoor air quality, Carbon dioxide, Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imelda Hospital, BonheidenUniversity, hospital or other
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Aranet4 Home CO2 monitorCO2 values on sensor visible to staff |
| Sham control | Sham comparator | Device: Aranet4 Home CO2 monitorCO2 values on sensor not visible to staff |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Double-bed hospital rooms
Key exclusion criteria (1 listed)
- Unoccupied rooms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aranet4 Home CO2 monitorThe sensor is placed in the room at a height between 1 and 2 meters and not near the window or door. | Device | Intervention, Sham control |
Primary outcome
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
3 secondary outcomes
Time >1000 ppm CO2
Time frame: 7 days/time period (pre-, active/sham and post-intervention)
Time >1400 ppm CO2
Time frame: 7 days/time period (pre-, active/sham and post-intervention)
Daily peak CO2 concentration [in ppm]
Time frame: 7 days/time period (pre-, active/sham and post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Derived from this study: PubMed 34728206Laurent 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.
- Individual participant dataSharing planned: Yes. The full set of sensor data will be made available to established investigators upon simple request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michaël R Laurent, MD PhD principal investigator
Geriatrics Department, Imelda Hospital Bonheiden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aranet4 Home CO2 monitor in people with Healthcare Associated Infection, run by Imelda Hospital, Bonheiden at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time >800 ppm CO2 (time frame: 7 days/time period (pre-, active/sham and post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.