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

NCT ID: NCT04770597

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-21

Study Completion Date

2021-05-02

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).

Conditions

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Healthcare Associated Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

CO2 values on sensor visible to staff

Group Type EXPERIMENTAL

Aranet4 Home CO2 monitor

Intervention Type DEVICE

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

Sham control

CO2 values on sensor not visible to staff

Group Type SHAM_COMPARATOR

Aranet4 Home CO2 monitor

Intervention Type DEVICE

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

Interventions

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Aranet4 Home CO2 monitor

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Double-bed hospital rooms

Exclusion Criteria

* Unoccupied rooms
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imelda Hospital, Bonheiden

OTHER

Sponsor Role lead

Responsible Party

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Michaël R Laurent, MD PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michaël R Laurent, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Geriatrics Department, Imelda Hospital Bonheiden

Locations

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Imelda Hospital

Bonheiden, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 34728206 (View on PubMed)

Other Identifiers

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20210209

Identifier Type: -

Identifier Source: org_study_id

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