Application Effect Analysis of Bundle Nursing Intervention

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.

Study Overview

• Status: Completed
• Conditions: Cross Infection; Interdisciplinary Communication; Nursing Care; Patient Care Bundles; Equipment and Supplies; Intensive Care Units (ICUs)
• Intervention / Treatment: Behavioral: routine ICU nursing; Behavioral: HAI prevention; Behavioral: prevention and control collaboration; 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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the control group; routine ICU nursing and HAI prevention and control protocols	Behavioral: 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.; Behavioral: 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.; Behavioral: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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).; Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of DAIs	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	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	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	days from admission to discharge	from admission to discharge, an average of about 53 days
mortality	death at discharge	assessment at discharge, an average of 53 days after admission

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection; Organization and Administration; Health Services Administration; Efficiency
• Other Study ID Numbers: QHDFS260421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No