Clinical trial NCT02400086: Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease
Official title: Study of Bacterial Colonization of the Respiratory Tract in Long-term Tracheostomized Patients With Neurological or Neuromuscular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Disorder of Trachea
Respiratory Tract Infections
Mechanical Ventilation Complication
Keywords: neuroligical or neuromuscular diseases
bacterial respiratory tract flora
long term tracheostomy
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient of majority age who signed the information note
* Tracheostomized patient for more than 6 months for a neurological or neuromuscular disease leaving in the community and hospitalized in Raymond Poincaré hospital for less than 48 hours

Exclusion Criteria:

* Refusal to take part of the study
* Not membership in a national insurance scheme
* Patient under guardianship or curatorship
* More than 48 hours hospitalization before tracheal aspirate
* Hospitalization in the previous month
* Evolutionary pneumonia at the admission or in the previous month (fever \>38.4°C with respiratory signs of pneumonia as cough, increase of the dyspnea, increase of expectorations associated with radiological opacities of recent appearance)
* Non-chronical antibiotic treatment in the previous month
* Patient already included during a previous hospitalization

Primary outcomes:
measure: Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Margaux Lepainteur, PhD
role: PRINCIPAL_INVESTIGATOR
References: