Application Effect Analysis of Bundle Nursing Intervention

NCT07656363 | Completed

• 1 other identifier: QHDFS260421
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patient Care Bundles; Interdisciplinary Communication; Intensive Care Units (ICUs); Equipment and Supplies; Cross Infection; Nursing Care

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

the control group

ACTIVE COMPARATOR

routine ICU nursing and HAI prevention and control protocols

Behavioral: routine ICU nursing; Behavioral: HAI prevention; Behavioral: prevention and control collaboration

the intervention group

EXPERIMENTAL

"Targeted Surveillance-Multidisciplinary Collaboration-Bundle Intervention" trinity system

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

Interventions

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.

the control group

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.

the control group

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.

the control group

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.

the intervention group

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.

the intervention group

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.

the intervention group

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).

the intervention group

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).

the intervention group

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

Qinhuangdao First Hospital

Qinhuangdao, Hebei, 066000, China

Location

MeSH Terms

Conditions

Cross Infection

Interventions

Efficiency

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 18, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)