Syndrome and Aspiration Pneumonia in Intensive Care

Completed

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

• Registration Number: NCT01881672
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation	ICU Discharge	Participants will be followed for the duration of ICU stay, an expected average of 4 days

Secondary Outcome Measures

Name	Time	Method
Identification of predictive factors for development of bacterial pneumonia	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.	ICU Discharge	Participants will be followed for the duration of ICU stay, an expected average of 4 days
Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation	ICU Discharge	Participants will be followed for the duration of ICU stay, an expected average of 4 days

Trial Locations

Locations (1)

CHD Vendee; 🇫🇷 La Roche Sur Yon, France