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

NCT04770597 | Completed

• 1 other identifier: 20210209
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthcare Associated Infection

Keywords

Indoor air quality; Carbon dioxide; Ventilation

Outcome Measures

Primary Outcomes (1)

• Time >800 ppm CO2

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

  7 days/time period (pre-, active/sham and post-intervention)

Secondary Outcomes (3)

• Time >1000 ppm CO2

  7 days/time period (pre-, active/sham and post-intervention)

• Time >1400 ppm CO2

  7 days/time period (pre-, active/sham and post-intervention)

• Daily peak CO2 concentration [in ppm]

  7 days/time period (pre-, active/sham and post-intervention)

Other Outcomes (2)

• Staff-rated feasibility on a 10-point Likert scale [0-10, with 10 indicating better outcome]

  7 days

• Staff-rated preference on a 10-point Likert scale [0-10, with 10 indicating better outcome]

  7 days

Study Arms (2)

Intervention

EXPERIMENTAL

CO2 values on sensor visible to staff

Device: Aranet4 Home CO2 monitor

Sham control

SHAM COMPARATOR

CO2 values on sensor not visible to staff

Device: Aranet4 Home CO2 monitor

Interventions

Aranet4 Home CO2 monitor DEVICE

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

Intervention; Sham control

Eligibility Criteria

• Gender Eligibility Details: When applicable, patients stay in double-bed rooms based on gender.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Double-bed hospital rooms

You may not qualify if:

• Unoccupied rooms

Sponsors & Collaborators

• Imelda Hospital, Bonheiden: lead

Study Sites (1)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34728206 DERIVED

MeSH Terms

Conditions

Cross Infection; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michaël R Laurent, MD PhD

  Geriatrics Department, Imelda Hospital Bonheiden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 25, 2021
• Study Start: February 21, 2021
• Primary Completion: May 2, 2021
• Study Completion: May 2, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available upon fulltext print publication in a peer-reviewed journal, for a duration of at least 10 years.
• Access Criteria: Simple e-mail request to the corresponding author by an established scientific investigator

Locations

BE (1)