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Application Effect Analysis of Bundle Nursing Intervention

15 de junio de 2026 actualizado por: Ranran Wang, The First Hospital of Qinhuangdao

Application Effect Analysis of Bundle Nursing Intervention Strategy Based on Targeted Surveillance in Reducing ICU Device-Associated Infections

This study aims to evaluate the impact of a multidisciplinary collaborative bundle nursing intervention based on targeted surveillance on the incidence of ICU device-associated infections (DAIs). The control group received routine nursing care, while the intervention group implemented a "targeted surveillance-multidisciplinary collaboration-bundle intervention" system. Infection rates, clinical outcomes, and intervention implementation were compared between the two groups.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Porcelana
    • Hebei
      • Qinhuangdao, Hebei, Porcelana, 066000
        • Qinhuangdao First Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Length of ICU stay ≥48 hours
  • receipt of at least one invasive device operation (urinary catheter, ventilator, or central venous catheter [CVC])
  • age ≥18 years
  • signed informed consent by the patient or family member (authorized representative for patients with impaired consciousness)

Exclusion Criteria:

  • Presence of DAI at admission;
  • failure to complete at least one targeted surveillance indicator record during hospitalization
  • voluntary discharge or loss to follow-up after transfer
  • combination of severe immunodeficiency diseases (e.g., AIDS, long-term use of immunosuppressants after organ transplantation)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: the control group
routine ICU nursing and HAI prevention and control protocols
Conductual: routine ICU nursing
For device care: urinary catheter daily cleaning (wiping the urethral orifice and proximal 5cm of the catheter with a dedicated sterile wet wipe twice a day); ventilator circuit replacement once a week (prompt replacement if contaminated or damaged); CVC exit site care: dressing change within 24 hours after catheter placement, film dressing replacement every 7 days, and gauze dressing replacement every 2 days.
Conductual: HAI prevention
the infection control department summarized infection data monthly, including the number of infections and pathogen types, and provided a paper report to the ICU without real-time data feedback or early warning mechanisms.
Conductual: prevention and control collaboration
the nursing department solely led HAI prevention and control. Temporary consultations with doctors and laboratory personnel were organized only in case of MDRO outbreaks or special infections, with no fixed collaboration process.
Experimental: the intervention group
"Targeted Surveillance-Multidisciplinary Collaboration-Bundle Intervention" trinity system
Conductual: real-time and precise monitoring

Daily records of urinary catheter, ventilator, and CVC dwell days; infection onset time ; pathogen type. APACHE II score (assessed at admission by doctors, calculated via HIS after morning rounds; responsible nurses assist at 8:00 daily); SOFA score (assessed at admission, calculated after morning rounds; nurses assist at 16:00 daily); consciousness status (GCS score).Compliance rate of bundle measures (qualified daily inspections/total cases); MDRO report response time (from lab report to isolation implementation).

Real-time monitoring automatically captured data via HIS/LIS and the Lanqingting platform, with daily updates of device use and vital signs. Regular analysis: weekly multidisciplinary meetings (Wednesdays 15:00) to review infection data and implementation issues. Early warning: infection rate thresholds (CAUTI >4.289‰, VAP >7.775‰, CLABSI >1.425‰); automatic alerts when thresholds exceeded or MDRO infections occurred.

Conductual: Multidisciplinary collaboration mechanism aimed for "efficiency and coordination."
A collaborative team: infection control (2 persons, data analysis & supervision), medical affairs (1, coordination & process optimization), nursing (2, training & implementation inspection), ICU (3 doctors + 5 nurses, assessment & measure execution), clinical lab (2, pathogen identification & rapid reporting), and clinical pharmacy (1, antimicrobial guidance). Upon MDRO detection, the lab reported identification and susceptibility via WeChat within 10 min. Clinicians issued isolation orders within 30 min. Nurses implemented contact isolation within 1 hour. Infection control staff conducted on-site supervision within 24 hours, documenting and providing feedback. Regular communication: weekly multidisciplinary meetings to review progress, discuss difficulties, and adjust interventions.
Conductual: CAUTI prevention and control
Strict aseptic intubation (maximum sterile barrier, hand hygiene before intubation, disinfection of the urethral orifice with 0.05% povidone-iodine twice); daily assessment of extubation indicators (assessment by doctors during morning rounds combined with patient condition and urinary function, extubation within 24 hours if eligible); closed drainage system (avoiding repeated opening of the drainage bag, keeping the urine collection bag below bladder level, replacement once a week); perineal care (wiping with 0.05% povidone-iodine twice a day, in the order of urethral orifice-vaginal orifice-anus). All the following diagnostic criteria must be simultaneously satisfied.
Conductual: VAP prevention and control
Semi-recumbent position (head of bed elevated 30-45°, adjusted and angle recorded every 2 hours); daily awakening trial (discontinuing sedatives at 9:00 daily to assess patient consciousness and spontaneous breathing ability, initiating weaning process if eligible); oral care (gargling with 0.12% chlorhexidine solution every 8 hours, wiping teeth, gums, and tongue surface; for non-intubated patients: gargling with 0.12% chlorhexidine solution twice a day, wiping teeth, gums, and tongue surface); continuous instillation of sterile water for injection (3 bottles per day, maintaining continuous moistening of the oral mucosa); replacement of ventilator circuit humidification fluid (using sterile distilled water, replacement once a day, maintaining water level within the standard range).
Conductual: CLABSI prevention and control
Aseptic intubation (selecting an appropriate puncture site, preferring ultrasound-guided puncture, maximum sterile barrier, skin disinfection with 2% chlorhexidine alcohol wiping ≥15cm in diameter, waiting for drying before intubation); daily assessment of extubation indicators (timely extubation if no clear indication based on treatment needs and patient condition); CVC exit site care (disinfection with 2% chlorhexidine alcohol, replacement of sterile dressings twice a week, prompt replacement if oozing or contamination occurs); avoiding unnecessary catheter maintenance (replacing dressings only when loose, contaminated, or in case of puncture site infection, avoiding routine catheter replacement).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
incidence of DAIs
Periodo de tiempo: from enrollment to transfer from the ICU or discharge, an average of 17 days
calculation method: the ratio of the number of DAI cases to the total number of device indwelling days of all patients in the group, multiplied by 1000‰
from enrollment to transfer from the ICU or discharge, an average of 17 days
duration of antimicrobial use
Periodo de tiempo: start from using antibiotics until discontinuation or discharge, an average of about 30 days
total days from antimicrobial initiation to discontinuation
start from using antibiotics until discontinuation or discharge, an average of about 30 days
length of ICU stay
Periodo de tiempo: from ICU admission to ICU transfer or discharge, an average of about 17 days
days from ICU admission to transfer or discharge
from ICU admission to ICU transfer or discharge, an average of about 17 days
total length of hospital stay
Periodo de tiempo: from admission to discharge, an average of about 53 days
days from admission to discharge
from admission to discharge, an average of about 53 days
mortality
Periodo de tiempo: assessment at discharge, an average of 53 days after admission
death at discharge
assessment at discharge, an average of 53 days after admission

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

The First Hospital of Qinhuangdao

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2023

Finalización primaria (Actual)

31 de diciembre de 2025

Finalización del estudio (Actual)

1 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • QHDFS260421

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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