Bacterial Colonization in Tracheostomized Patients With Neurological or Neuromuscular Disease

NCT02400086 | Completed

• 1 other identifier: 15004
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

neuroligical or neuromuscular diseases; bacterial respiratory tract flora; long term tracheostomy

Outcome Measures

Primary Outcomes (1)

• Description of the bacterial flora of the respiratory tract identify by tracheal aspirate at the hospital admission of long-term tracheostomized patients

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with a long-term tracheostomy and suffering from a neurological or neuromuscular disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead

Study Sites (1)

Hôpital Raymond Poincaré

Garches, 92380, France

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Nervous System Diseases

Study Officials

• Margaux Lepainteur, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

FR (1)