Skip to content

Care Bundle to Limit External Ventricular Drain Associated iNfections

Care Bundle to Limit External Ventricular Drain Associated iNfections

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07619625
Acronym
CLEAN-EVD
Enrollment
248
Registered
2026-06-02
Start date
2026-06-01
Completion date
2028-12-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Associated Infection

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.

Interventions

OTHERBundle of measures including updated care protocoles and training of residents, nurses and nurses assistants

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward.From the inclusion up to 30 daysNumber of infections according to the 2017. Altération de la biochimie du LCR. Clinical deterioration of the patient

Secondary

MeasureTime frameDescription
Occurrence of a contamination related to EVDsFrom the inclusion up to 30 days.Number of contamination according to : CSF with a single positive culture or a direct examination with Gram staining showing a microorganism, without any alteration in CSF biochemistry and without clinical deterioration. CSF contamination corresponds to the detection of microorganisms in a CSF sample that do not originate from the site being studied (CSF).
Occurrence of a colonisation related to EVDsFrom the inclusion up to 30 days.Number of colonisation according to CSF with multiple positive cultures or multiple direct examinations with Gram staining showing a microorganism, without any alteration in CSF biochemistry and without clinical deterioration. CSF colonization corresponds to the presence of microorganisms in the CSF without any associated clinical manifestations.

Contacts

CONTACTJulie Borovik
borovik.j@chu-nice.fr06 98 86 83 50
CONTACTPauline Duchemin
duchemin.p@chu-nice.fr0602650248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026