Care Bundle to Limit External Ventricular Drain Associated iNfections
CLEAN-EVD
1 other identifier
observational
248
0 countries
N/A
Brief Summary
The aim of our study is to reduce the incidence of External ventricular drain (EVD)-related infections by implementing a bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants. At Nice University Hospital, we are conducting a retrospective study showing a 22% infection rate associated with EVD. The identified pathogens are mainly transmitted by manual contact. Additionnally, high turnover among paramedical staff and sometimes rapid training may contribute to infection ocurrence. We hypothesize that a significant proportion of patients with EVD develop nosocomial ventriculitis, primarily due to modificable risk factors such as catheter handling and breaches in aseptic technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
June 2, 2026
May 1, 2026
2.3 years
May 26, 2026
May 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward.
Number of infections according to the 2017. Altération de la biochimie du LCR. Clinical deterioration of the patient
From the inclusion up to 30 days
Secondary Outcomes (2)
Occurrence of a contamination related to EVDs
From the inclusion up to 30 days.
Occurrence of a colonisation related to EVDs
From the inclusion up to 30 days.
Study Arms (1)
EVD-associated infection cohort in CIU and step-down care
Interventions
Preventive measures are structured around several key areas : updating the EVD insertion protocol and the EVD care protocol, optimizing dressing changes and scalp cleansing ; ; creation of reminder signage displayed outside the rooms of patients with an EVD outlining key hygiene rules ; implementation of theoretical teaching and simulation sessions for residents and nurses, covering EVD management, infectious complications, their treatment, and prevention ; assessment through a questionnaire on EVD management before implementation of preventive measures and after.
Eligibility Criteria
The study population consists of adult patients admitted to the general intensive care and intermediate care units of Nice University Hospital who underwent EVD placement on site.
You may qualify if:
- Age ≥ 18 years.
- Hospitalized in a general intensive care unit or intermediate care unit at Nice University Hospital.
- Having undergone EVD placement within the institution.
You may not qualify if:
- EVD placed outside the institution with no possibility of follow-up.
- Patient under immediate therapeutic limitation.
- Pre-existing neuromeningeal infection.
- Expression by the patient or by the trusted person of opposition to the processing of the patient's medical data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2026
First Posted
June 2, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
June 2, 2026
Record last verified: 2026-05