Syndrome and Aspiration Pneumonia in Intensive Care

ICU Patients Clinical Trial

— SPIRE  

Official title:

Syndrome and Aspiration Pneumonia in Intensive Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881672
• Other study ID #: SPIRE
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: August 25, 2016
• Start date: November 2012
• Est. completion date: April 2015

Study information

• Verified date: August 2016
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ICU Patients
• In State of Coma (Define by Glasgow = 8)
• No Antibiotic Treatment
• Pneumonia
• Pneumonia, Aspiration
• Under Mechanical Ventilation

Locations

Country	Name	City	State
France	CHD Vendee	La Roche Sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No