Syndrome and Aspiration Pneumonia in Intensive Care

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

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Key information

Conditions

ICU Patients Coma Consciousness Disorders In State of Coma (Define by Glasgow ≤ 8) Infections Lung Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations No Antibiotic Treatment Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Unconsciousness Under Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHD Vendee

La Roche-sur-Yon, 85000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Acronym: SPIRE

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jun 20, 2013
Registry last updated: Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed