- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01881672
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
Studieöversikt
Status
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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La Roche Sur Yon, Frankrike, 85000
- CHD Vendée
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Coma patients in ICU under mechanical ventilation
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
Tidsram: ICU Discharge
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Participants will be followed for the duration of ICU stay, an expected average of 4 days
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ICU Discharge
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation
Tidsram: ICU Discharge
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Participants will be followed for the duration of ICU stay, an expected average of 4 days
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ICU Discharge
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Description of the bacterial flora identified in respiratory specimens.
Tidsram: ICU Discharge
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Participants will be followed for the duration of ICU stay, an expected average of 4 days
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ICU Discharge
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Identification of predictive factors for development of bacterial pneumonia
Tidsram: ICU Discharge
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Participants will be followed for the duration of ICU stay, an expected average of 4 days
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ICU Discharge
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SPIRE
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