Application Effect Analysis of Bundle Nursing Intervention
2026年6月15日 更新者：Ranran Wang、The First Hospital of Qinhuangdao
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.
調査の概要
状態
完了
介入・治療
研究の種類
介入
入学 (実際)
120
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hebei
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Qinhuangdao、Hebei、中国、066000
- Qinhuangdao First Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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incidence of DAIs
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年1月1日
一次修了 (実際)
2025年12月31日
研究の完了 (実際)
2026年4月1日
試験登録日
最初に提出
2026年4月21日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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