Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease — ECOTRACH  

Respiratory Tract Infections Clinical Trial

Official title: Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease

Status Completed

Clinical Trial Summary

Patients with neurological or neuromuscular diseases may need a long-term tracheostomy to improve their respiratory function. Bacterial flora and bacterial drug resistance in the respiratory tract have never been studied until then for this type of patient in spite of their frequent hospital stay, their regular exposition to antibiotics and their susceptibility to swallowing disorders due to their pathology. This study is based on a single tracheal aspirate within the 48 first hours of the patient stay for a ventilation check up beside any infectious context to describe the basal bacterial respiratory flora.

Clinical Trial Description

At their admission in Raymond Poincaré hospital in the long-term ventilation unit for a ventilation check-up, patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease will be included in the study if they have no sign of pneumonia and no contact with a hospital structure within a month. These exclusion criteria allow to focus on non-decompensating patient with a respiratory flora not hospital-acquired and not modified by antibiotics.

The doctor in charge of the patient will fill a questionnaire with the help of the patients or the patient's family with several items as date of tracheostomy, history of respiratory infections, history of hospitalization, characteristics of ventilation (presence of a cannula, frequency of change of filter, type of water use in the humidifier…). Beside, a tracheal aspirate will be collected and send to the microbiology laboratory for bacterial culture. The tracheal aspirate will be supported as a usual clinical tracheal aspirate but each bacterial specie will be quantify and identify by mass spectrometry. Antimicrobial susceptibility testing will be performed only for potential pathogenic species with a cut-off at 105. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Disorder of Trachea
• Mechanical Ventilation Complication
• Neuromuscular Diseases
• Respiratory Tract Infections
• Tracheal Diseases

• NCT number: NCT02400086
• Study type: Observational
• Source: Centre d'Investigation Clinique et Technologique 805
• Status: Completed
• Start date: February 2015
• Completion date: January 2018