Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease

NCT ID: NCT02400086

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 77 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-01-31

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.

Conditions

Infectious Disorder of Trachea; Respiratory Tract Infections; Mechanical Ventilation Complication

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaux Lepainteur, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Raymond Poincaré

Garches, , France

Countries

France

Other Identifiers

15004

Identifier Type: -

Identifier Source: org_study_id