- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07656363
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Verhalten: routine ICU nursing
- Verhalten: HAI prevention
- Verhalten: prevention and control collaboration
- Verhalten: real-time and precise monitoring
- Verhalten: Multidisciplinary collaboration mechanism aimed for "efficiency and coordination."
- Verhalten: CAUTI prevention and control
- Verhalten: VAP prevention and control
- Verhalten: CLABSI prevention and control
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Hebei
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Qinhuangdao, Hebei, China, 066000
- Qinhuangdao First Hospital
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: the control group
routine ICU nursing and HAI prevention and control protocols
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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 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 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.
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Experimental: the intervention group
"Targeted Surveillance-Multidisciplinary Collaboration-Bundle Intervention" trinity system
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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.
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.
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.
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).
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).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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incidence of DAIs
Zeitfenster: from enrollment to transfer from the ICU or discharge, an average of 17 days
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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‰
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from enrollment to transfer from the ICU or discharge, an average of 17 days
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duration of antimicrobial use
Zeitfenster: start from using antibiotics until discontinuation or discharge, an average of about 30 days
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total days from antimicrobial initiation to discontinuation
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start from using antibiotics until discontinuation or discharge, an average of about 30 days
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length of ICU stay
Zeitfenster: from ICU admission to ICU transfer or discharge, an average of about 17 days
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days from ICU admission to transfer or discharge
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from ICU admission to ICU transfer or discharge, an average of about 17 days
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total length of hospital stay
Zeitfenster: from admission to discharge, an average of about 53 days
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days from admission to discharge
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from admission to discharge, an average of about 53 days
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mortality
Zeitfenster: assessment at discharge, an average of 53 days after admission
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death at discharge
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assessment at discharge, an average of 53 days after admission
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- QHDFS260421
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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