Application Effect Analysis of Bundle Nursing Intervention Strategy Based on Targeted Surveillance in Reducing ICU Device-Associated Infections
| Registry | NCT07656363 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 120 (Actual) |
| Sponsor | The First Hospital of Qinhuangdao (Other gov) |
| Conditions | Patient Care Bundles, Interdisciplinary Communication, Intensive Care Units (ICUs), Equipment and Supplies, Cross Infection, Nursing Care |
| Interventions | routine ICU nursing, HAI prevention, prevention and control collaboration, real-time and precise monitoring, Multidisciplinary collaboration mechanism aimed for "efficiency and coordination.", CAUTI prevention and control, VAP prevention and control, CLABSI prevention and control (Behavioral) |
| Dates | start 2023-01-01, primary completion 2025-12-31, completion 2026-04-01, first posted 2026-06-18, last updated 2026-06-18 |
| Locations | 1 site in China |
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-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| the control group | Active comparator | Behavioral: routine ICU nursing; Behavioral: HAI prevention; Behavioral: prevention and control collaboration | routine ICU nursing and HAI prevention and control protocols |
| the intervention group | Experimental | Behavioral: real-time and precise monitoring; Behavioral: Multidisciplinary collaboration mechanism aimed for "efficiency and coordination."; Behavioral: CAUTI prevention and control; Behavioral: VAP prevention and control; Behavioral: CLABSI prevention and control | "Targeted Surveillance-Multidisciplinary Collaboration-Bundle Intervention" trinity system |
- routine ICU nursing (Behavioral): 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.
- HAI prevention (Behavioral): 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.
- prevention and control collaboration (Behavioral): 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.
- real-time and precise monitoring (Behavioral): 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.
- Multidisciplinary collaboration mechanism aimed for "efficiency and coordination." (Behavioral): 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.
- CAUTI prevention and control (Behavioral): 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.
- VAP prevention and control (Behavioral): 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).
- CLABSI prevention and control (Behavioral): 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).
+Outcome measures
Primary outcomes
- incidence of DAIs [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‰
- duration of antimicrobial use [start from using antibiotics until discontinuation or discharge, an average of about 30 days]: total days from antimicrobial initiation to discontinuation
- length of ICU stay [from ICU admission to ICU transfer or discharge, an average of about 17 days]: days from ICU admission to transfer or discharge
- total length of hospital stay [from admission to discharge, an average of about 53 days]: days from admission to discharge
- mortality [assessment at discharge, an average of 53 days after admission]: death at discharge
+Eligibility
Sex: All, ages: 18 Years to 86 Years
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)
+Locations (1)
| Facility | City | Country | Status |
|---|
| Qinhuangdao First Hospital | Qinhuangdao, Hebei | China | |