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OpenTrials
Completed

NCT Number: NCT03108430

Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Inhalation pneumonia (PI) is common in clinical practice but is rarely studied. For example, there are no data on the incidence of pneumonia after inhalation and risk factors or protective factors to develop one since it is known that anyone who inhaled does not necessarily develop an IP. There is no data on the benefit of treating inhalation by antibiotic therapy pre-emptively although this practice is common. In this context, this observational study wishes to take stock of the situation on the subject in order to determine what actions to implement to prevent IP.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • In intensive care: Any intubated patient who presented:
  • It is a coma with GCS ≤ 12 without VAS protection, whatever the duration
  • Either a proven inhalation, defined by the presence in the VAS of gastric fluid or food
  • Either a suspected inhalation, defined by the extrahospital anamnesis
  • In medicine :
  • Any wrong way (defined by a reflex cough when taking food)
  • Coma without intubation, regardless of duration or depth

Exclusion criteria

  • Patients with VAP

Treatment and study plan

Risk factors and incidence of IP after inhalation

Other

Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.

Primary outcomes

  1. Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: PrevAsPI-Obs

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2017
Registry last updated
Jun 16, 2026

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.

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