Key to Improve DiagNosis in Aspiration Pneumonia

Completed

• Conditions: Coma; Infectious Pneumonia

• Registration Number: NCT03182387
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

Detailed Description

Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

Study Timeline

• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Study Start: 2017-08-21
• Primary Completion: 2020-11-19
• Study Completion: 2020-11-19
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
• Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C).
• Age ≥18 years
• Patient affiliated to the social security system.
• No opposition obtained

Exclusion Criteria

• Immunocompromised patient.
• Cardiorespiratory arrest requiring therapeutic hypothermia.
• Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission).
• Infectious Pneumonia in the previous 30 days.
• Previous hospitalization in the previous 30 days.
• Patient under antibiotic at baseline.
• Bacteremia.
• Mechanical ventilation begun before unconsciousness.
• Report Pa02 / FI02 <80.
• Patient under curatorship and / or guardianship.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificityof amylase test.	5 days after inclusion day	Amylase culture in bronchoalveolar fluid is compared to gold standard culture

Trial Locations

Locations (1)

Hôpital Pellegrin; 🇫🇷 Bordeaux, France