Care Bundle to Limit External Ventricular Drain Associated iNfections

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.

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Key information

Conditions

Health Care Associated Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

Occurrence of an infection related to EVDs between the day of insertion and up to 30 daysafterward.

Time frame: From the inclusion up to 30 days

Number of infections according to the 2017. Altération de la biochimie du LCR. Clinical deterioration of the patient

Secondary outcomes

Occurrence of a contamination related to EVDs

Time frame: From 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 EVDs

Time frame: From 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Borovik

CONTACT

[email protected]

06 98 86 83 50

Pauline Duchemin

CONTACT

[email protected]

0602650248

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Acronym: CLEAN-EVD

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jun 2, 2026
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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