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Application Effect Analysis of Bundle Nursing Intervention

15 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

120

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • China
    • Hebei
      • Qinhuangdao, Hebei, China, 066000
        • Qinhuangdao First Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: the control group
routine ICU nursing and HAI prevention and control protocols
Comportamental: 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.
Comportamental: 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.
Comportamental: 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
Comportamental: 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.

Comportamental: 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.
Comportamental: 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.
Comportamental: 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).
Comportamental: 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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
incidence of DAIs
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The First Hospital of Qinhuangdao

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2023

Conclusão Primária (Real)

31 de dezembro de 2025

Conclusão do estudo (Real)

1 de abril de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • QHDFS260421

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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