Key to Improve DiagNosis in Aspiration Pneumonia

Coma Clinical Trial

— KIDNAP  

Official title:

Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03182387
• Other study ID #: CHUBX 2015/38
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: November 19, 2020

Study information

• Verified date: June 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coma
• Infectious Pneumonia
• Pneumonia

Locations

Country	Name	City	State
France	Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificityof amylase test.	Amylase culture in bronchoalveolar fluid is compared to gold standard culture	5 days after inclusion day