Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Sirio-Libanes | OTHER |
| Hospital do Coracao | OTHER |
| Beneficência Portuguesa de São Paulo | OTHER |
Not provided
Not provided
Not provided
Not provided
Healthcare-associated infections (HAIs) remain a major problem in intensive care units (ICUs), driven by environmental contamination with multidrug-resistant organisms that persist despite routine manual cleaning. While hydrogen peroxide aerosolization and ultraviolet-C light devices have shown promise in reducing surface contamination, current evidence is inconsistent, mostly derived from single-center studies, and rarely linked to patient-centered outcomes.
The investigators will conduct this cluster-randomized, crossover trial in 12 Brazilian ICUs. Each ICU will sequentially implement three strategies: (1) usual surface disinfection; (2) usual surface disinfection followed by hydrogen peroxide aerosolization at 7.9% concentration, applied through a dedicated device inside a protective tent during terminal cleaning of patient beds; and (3) usual surface disinfection followed by automated ultraviolet-C irradiation, also applied under the same tent to shield adjacent occupied beds.
The primary outcome will be the antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days, with secondary outcomes including HAI incidence rate, environmental contamination with multidrug-resistant organisms, specific HAIs incidence rate (associated-ventilator pneumonia, central-line associated bloodstream infection, and catheter-associated urinary tract infection), and ICU length of stay costs.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surface disinfection with aerosolized hydrogen peroxide | Experimental | The hygiene team of each participating ICU will spray aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge. As peroxide hydrogen aerosol can be irritating to people nearby, we will use a tent designed to cover the bed and nearby equipment during peroxide hydrogen disinfection, thus preventing aerosols from spreading to other beds and other areas of ICUs where beds are not in closed rooms. |
|
| Surface disinfection with irradiation of ultraviolet light | Experimental | The hygiene team of each participating ICU will use a specific device, requiring no manipulation, for irradiating UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning. To prevent UV irradiation from reaching occupied beds and other areas of the ICU, the same tent described in the "peroxide hydrogen" arm. |
|
| Usual disinfection | No Intervention | The control group will perform standard cleaning and disinfection of the beds and the environment according to their previous protocols, using the usual products. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosol of hydrogen peroxide | Other | Spray of aerosolized peroxide hydrogen using a specific device when performing terminal cleaning of the ICU bed after the patient's discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial utilization at the ICU level | Antimicrobial utilization, measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare-associated infections | Incidence rate of device healthcare-associated infections during ICU admission | 3 months |
| Contamination of environmental surfaces by multi-resistant microorganisms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio P Nassar Jr, PhD | Contact | 551121519617 | antonio.nassar@einstein.br | |
| Adriano J Pereira, PhD | Contact | 551121519617 | Adriano.Pereira2@einstein.br |
| Name | Affiliation | Role |
|---|---|---|
| Antonio P Nassar Jr, PhD | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Maternidade Sao Vicente De Paulo | Recruiting | Barbalha | Ceará | Brazil |
The sharing of individual participant data is subject to approval by the Institutional Review Boards and the Brazilian Ministry of Health.
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, controlled, cluster, crossover, trial
Not provided
Not provided
Not provided
|
| Irradiation of ultraviolet light | Other | Irradiation of UV light for the purpose of disinfecting beds and surfaces near beds during terminal cleaning. |
|
|
We will collect environmental samples from 4 surfaces highly touched by the patient, health team and family (bed rails, monitor and infusion pump buttons, meal table or procedure table, and IV drip stand) before and after the intervention. For analysis of the environmental samples, characterization of the density and microbiological profile of biofilms on the different surfaces of the ICU beds will be performed using large-scale DNA sequencing techniques associated with bioinformatics analysis.
| 3 months |
| Incidence density of ventilator-associated pneumonia | 3 months |
| Incidence density of central line-associated bloodstream infections | 3 months |
| Incidence density of catheter-associated urinary tract infection | 3 months |
| Intensive care unit length of stay costs | 3 months |
| Instituto Hospital de Base | Recruiting | Brasília | Federal District | Brazil |
|
| Hospital Estadual de Aparecida de Goiânia | Recruiting | Aparecida de Goiânia | Goiás | Brazil |
|
| Santa Casa de Misericórdia de Passos | Recruiting | Passos | Minas Gerais | Brazil |
|
| Fundo Municipal de Saúde de Maringá | Recruiting | Maringá | Paraná | Brazil |
|
| Hospital da Restauração | Recruiting | Recife | Pernambuco | Brazil |
|
| Hospital Universitário da Universidade Federal do Piauí | Recruiting | Teresina | Piauí | Brazil |
|
| Hospital Universitário Onofre Lopes | Recruiting | Natal | Rio Grande do Norte | Brazil |
|
| Hospital Geral de Caxias do Sul | Recruiting | Caxias do Sul | Rio Grande do Sul | Brazil |
|
| Hospital de Pronto Socorro de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | Brazil |
|
| Hospital Dr Leo Orsi Bernardes | Recruiting | Itapetininga | São Paulo | Brazil |
|
| Hospital Pelópidas Silveira | Recruiting | Recife | Brazil |
|
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D014552 | Urinary Tract Infections |
| D053717 | Pneumonia, Ventilator-Associated |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006861 | Hydrogen Peroxide |
| D014466 | Ultraviolet Rays |
| ID | Term |
|---|---|
| D010545 | Peroxides |
| D010087 | Oxides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D011840 | Radiation, Nonionizing |
| D013472 | Sunlight |
| D014887 | Weather |
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
Not provided
Not provided