Syndrome and Aspiration Pneumonia in Intensive Care (SPIRE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre Hospitalier Departemental Vendee
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier:
NCT01881672
First received: June 13, 2013
Last updated: December 30, 2013
Last verified: December 2013
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of ICU stay, an expected average of 4 days


Estimated Enrollment: 250
Study Start Date: November 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coma patients in ICU under mechanical ventilation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  • Lack of social security
  • Refusal of the patient or their next of kind
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881672

Contacts
Contact: Jean Baptiste Lascarrou, MD 33251446554 jean-baptiste.lascarrou@chd-vendee.fr

Locations
France
CHD Vendee Recruiting
La Roche Sur Yon, France, 85000
Contact: Jean Baptiste Lascarrou, MD    33251446554    jean-baptiste.lascarrou@chd-vendee.fr   
Principal Investigator: Jean Baptiste Lascarrou, MD         
Sub-Investigator: Jean Reignier, MD, PhD         
Sub-Investigator: Konstantinos Bachoumas, MD         
Sub-Investigator: Isabelle Vinatier, MD         
Sub-Investigator: Laurent Martin-Lefevre, Md         
Sub-Investigator: Matthieu Henry-Lagarrigue, MD         
Sub-Investigator: Christine Lebert, MD         
Sub-Investigator: Gwenhael Colin, MD         
Sub-Investigator: Maud Fiancette, MD         
Sub-Investigator: Aihem Yehia, MD         
Sub-Investigator: Jean Claude Lacherade, MD         
Sub-Investigator: Floriane Lissonde, Resident         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Principal Investigator: Jean Baptiste Lascarrou, MD CHD Vendee
  More Information

No publications provided

Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT01881672     History of Changes
Other Study ID Numbers: SPIRE
Study First Received: June 13, 2013
Last Updated: December 30, 2013
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Coma
Pneumonia
Pneumonia, Aspiration
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014