Syndrome and Aspiration Pneumonia in Intensive Care (SPIRE)

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

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• France
  • La Roche Sur Yon, France, 85000
    • CHD Vendee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Coma patients in ICU under mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantify the use of antibiotics during the ICU stay for 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
Description of the bacterial flora identified in respiratory specimens.	Participants will be followed for the duration of ICU stay, an expected average of 4 days	ICU Discharge
Identification of predictive factors for development of bacterial pneumonia	Participants will be followed for the duration of ICU stay, an expected average of 4 days	ICU Discharge

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): August 26, 2016
• Last Update Submitted That Met QC Criteria: August 25, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Coma; Aspiration pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Aspiration
• Other Study ID Numbers: SPIRE