Application Effect Analysis of Bundle Nursing Intervention

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 86 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

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

Being tested

routine ICU nursing, HAI prevention, prevention and control collaboration, real-time and precise monitoring, Multidisciplinary collaboration mechanism aimed for "efficiency and coordination."

Medical subject headings

Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• routine ICU nursingBehavioural

  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 preventionBehavioural

  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 collaborationBehavioural

  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 monitoringBehavioural

  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."Behavioural

  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 controlBehavioural

  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 controlBehavioural

  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 controlBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. 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‰

   Measured: from enrollment to transfer from the ICU or discharge, an average of 17 days

2. duration of antimicrobial use

   total days from antimicrobial initiation to discontinuation

   Measured: start from using antibiotics until discontinuation or discharge, an average of about 30 days

3. length of ICU stay

   days from ICU admission to transfer or discharge

   Measured: from ICU admission to ICU transfer or discharge, an average of about 17 days

4. total length of hospital stay

   days from admission to discharge

   Measured: from admission to discharge, an average of about 53 days

5. mortality

   death at discharge

   Measured: assessment at discharge, an average of 53 days after admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Jun 2026
2. Study start1 Jan 2023
3. Primary completion31 Dec 2025
4. Study completion1 Apr 2026

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Patient Care BundlesStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.