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Key to Improve DiagNosis in Aspiration Pneumonia

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03182387
Acronym
KIDNAP
Enrollment
69
Registered
2017-06-09
Start date
2017-08-21
Completion date
2020-11-19
Last updated
2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coma, Infectious Pneumonia

Keywords

Bronchoalveolar lavage, amylase assay, aspiration pneumonia

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.

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificityof amylase test.5 days after inclusion dayAmylase culture in bronchoalveolar fluid is compared to gold standard culture

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026