Syndrome and Aspiration Pneumonia in Intensive Care

NCT01881672 | Completed

• 1 other identifier: SPIRE
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Aspiration pneumonia; Coma; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation

  Participants will be followed for the duration of ICU stay, an expected average of 4 days

  ICU Discharge

Secondary Outcomes (3)

• Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation

  ICU Discharge

• Description of the bacterial flora identified in respiratory specimens.

  ICU Discharge

• Identification of predictive factors for development of bacterial pneumonia

  ICU Discharge

Study Arms (1)

Coma patients in ICU under mechanical ventilation

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 hospitalized in ICU for coma (define by Glasgow score \< 8) and under mechanical ventilation. Suspicion of bacterial inhalation pneumonia will be confirme by a protected distal sampling during a flexible bronchoscopy.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

CHD Vendee

La Roche-sur-Yon, 85000, France

Location

MeSH Terms

Conditions

Pneumonia, Aspiration; Coma

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Baptiste Lascarrou, MD

  CHD Vendee

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 20, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

FR (1)