ClinicalTrials.gg
CompletedNCT07656363Updated Jun 18, 2026

Application Effect Analysis of Bundle Nursing Intervention

An interventional study of routine ICU nursing and HAI prevention in Patient Care Bundles, Interdisciplinary Communication and Intensive Care Units (ICUs), sponsored by The First Hospital of Qinhuangdao. Completed at 1 site in China. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by The First Hospital of Qinhuangdao · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2023, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 86 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Cross Infection with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Cross Infection · China.

Started
2023
the only one that year
No phase
6 of 10
2 open now
Registered
10th of 10
by date
Lead sponsor
1 of 10
The First Hospital of Qinhuangdao

Among the 10 studies in Cross Infection with a site in China, this one is the only one that started in 2023, is one of 6 with no phase, and was the 10th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phasethis study6 · 2 open
Observational3 · 0 open
Phase 31 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 372 across the 7 interventional studies, 500 across the 3 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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.

03

Conditions studied

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

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04

Who can participate

Ages eligible
18 Years to 86 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by the patient or family member (authorized representative for patients with impaired consciousness)

Exclusion criteria

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 after organ transplantation)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    the control group

    routine ICU nursing and HAI prevention and control protocols

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

  • Experimental
    the intervention group

    "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

  • Behavioralroutine 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.

  • BehavioralHAI 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.

  • Behavioralprevention 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.

  • Behavioralreal-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.

  • BehavioralMultidisciplinary 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.

  • BehavioralCAUTI 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.

  • BehavioralVAP 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).

  • BehavioralCLABSI 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).

06

What researchers measure

Primary outcomes

  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‰

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  5. mortality

    death at discharge

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

07

Study locations

1 site
  • Qinhuangdao First Hospital
    Qinhuangdao, Hebei 066000, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Dec 2025, 35 months.

Of 57 non-industry interventional studies with no phase under Cross Infection, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 35 months is above that.

Counting every sponsor, half of 59 studies reached it within 16 months; a quarter within 6 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2026
First posted
Jun 18, 2026
StartActual
Jan 1, 2023
Primary completionActual
Dec 31, 2025
CompletionActual
Apr 1, 2026
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07656363
Lead sponsor
The First Hospital of Qinhuangdao
Responsible party
Ranran Wang (Doctor, The First Hospital of Qinhuangdao) — Principal investigator
First posted
Jun 18, 2026
Start date
Jan 1, 2023
Primary completion
Dec 31, 2025
Completion
Apr 1, 2026
Last update
Jun 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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