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Syndrome and Aspiration Pneumonia in Intensive Care (SPIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881672
First Posted: June 20, 2013
Last Update Posted: August 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
  Purpose

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


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Syndrome and Aspiration Pneumonia in Intensive Care

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Departemental Vendee:

Primary Outcome Measures:
  • Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation [ Time Frame: ICU Discharge ]
    Participants will be followed for the duration of ICU stay, an expected average of 4 days


Secondary Outcome Measures:
  • Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation [ Time Frame: ICU Discharge ]
    Participants will be followed for the duration of ICU stay, an expected average of 4 days

  • Description of the bacterial flora identified in respiratory specimens. [ Time Frame: ICU Discharge ]
    Participants will be followed for the duration of ICU stay, an expected average of 4 days

  • Identification of predictive factors for development of bacterial pneumonia [ Time Frame: ICU Discharge ]
    Participants will be followed for the duration of ICU stay, an expected average of 4 days


Estimated Enrollment: 250
Study Start Date: November 2012
Study Completion Date: April 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coma patients in ICU under mechanical ventilation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881672


Locations
France
CHD Vendee
La Roche Sur Yon, France, 85000
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Principal Investigator: Jean Baptiste Lascarrou, MD CHD Vendee
  More Information

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01881672     History of Changes
Other Study ID Numbers: SPIRE
First Submitted: June 13, 2013
First Posted: June 20, 2013
Last Update Posted: August 26, 2016
Last Verified: August 2016

Keywords provided by Centre Hospitalier Departemental Vendee:
Aspiration pneumonia
Coma
Mechanical ventilation

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections