Syndrome and Aspiration Pneumonia in Intensive Care

NCT ID: NCT01881672

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-04-30

Brief Summary

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Inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of ICU stay increased. However, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known.

The aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation

Detailed Description

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Conditions

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ICU Patients Under Mechanical Ventilation In State of Coma (Define by Glasgow ≤ 8) No Antibiotic Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coma patients in ICU under mechanical ventilation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Altered consciousness defined by a Glasgow Coma Scale score less than or equal to 8 before protection of the upper airway by endotracheal intubation
* Patient under mechanical ventilation

Exclusion Criteria

* Patient with pre-existing impairment of laryngeal function in Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, laryngeal cancer, radiotherapy laryngeal
* Patient under guardianship
* Inpatient without consent
* Pregnant woman
* Patient previously treated with antibiotics for more than 24 hours at the time of ICU admission
* Patient with infection at ICU admission which justified probabilist antibiotic treatment
* Lack of social security
* Refusal of the patient or their next of kind
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean Baptiste Lascarrou, MD

Role: PRINCIPAL_INVESTIGATOR

CHD Vendee

Locations

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CHD Vendee

La Roche-sur-Yon, , France

Site Status

Countries

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France

Other Identifiers

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SPIRE

Identifier Type: -

Identifier Source: org_study_id

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