We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Syndrome and Aspiration Pneumonia in Intensive Care (SPIRE)

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.
ClinicalTrials.gov Identifier: NCT01881672
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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


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

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Syndrome and Aspiration Pneumonia in Intensive Care
Study Start Date : November 2012
Primary Completion Date : March 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma Pneumonia
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Coma patients in ICU under mechanical ventilation


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: June 20, 2013    Key Record Dates
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