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Not yet recruiting NCT07619625

Care Bundle to Limit External Ventricular Drain Associated iNfections

Observational Health Care Associated Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bundle of measures including updated care protocoles and training of residents, nurses and nurses assistants.
Who it may be relevant to
Registry conditions: Health Care Associated Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Occurrence of a contamination related to EVDs [Time frame: From the inclusion up to 30 days.]
  • Occurrence of a colonisation related to EVDs [Time frame: From the inclusion up to 30 days.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07619625 · 26Anesthesie-Réa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗