Care Bundle to Limit External Ventricular Drain Associated iNfections (CLEAN-EVD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Care Associated Infection
• Intervention / Treatment: Other: Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants

• Study Type: Observational
• Enrollment (Estimated): 248

Contacts and Locations

• Study Contact: Name: Julie Borovik; Phone Number: 06 98 86 83 50; Email: borovik.j@chu-nice.fr
• Study Contact Backup: Name: Pauline Duchemin; Phone Number: 0602650248; Email: duchemin.p@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

EVD-associated infection cohort in CIU and step-down care

Other: Bundle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of a contamination related to EVDs	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).	From the inclusion up to 30 days.
Occurrence of a colonisation related to EVDs	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.	From the inclusion up to 30 days.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Cross Infection; Health Care Facilities Workforce and Services; Health Personnel; Nurses
• Other Study ID Numbers: 26Anesthesie-Réa

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No