Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation (PrevAsPI-Obs)

April 5, 2017 updated by: Centre Hospitalier Universitaire, Amiens
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Observation of inhalations in medicine and resuscitation and collection of data likely to influence the emergence of an IP.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inhalation pneumonia
Other: Risk factors and incidence of IP after inhalation
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.
Proven inhalations
Other: Risk factors and incidence of IP after inhalation
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.
Suspected inhalations (coma + anamnesis)
Other: Risk factors and incidence of IP after inhalation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2016

Primary Completion (ANTICIPATED)

August 21, 2017

Study Completion (ANTICIPATED)

August 21, 2017

Study Registration Dates

First Submitted

March 31, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (ACTUAL)

April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI2016-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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