NCT03108430

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

12 months

First QC Date

March 31, 2017

Last Update Submit

April 5, 2017

Conditions

Outcome Measures

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.

    1 day

Study Arms (3)

Inhalation pneumonia

Other: Risk factors and incidence of IP after inhalation

Proven inhalations

Other: Risk factors and incidence of IP after inhalation

Suspected inhalations (coma + anamnesis)

Other: Risk factors and incidence of IP after inhalation

Interventions

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.

Inhalation pneumoniaProven inhalationsSuspected inhalations (coma + anamnesis)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with VAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Central Study Contacts

Jean-Philippe LANOIX, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 11, 2017

Study Start

August 22, 2016

Primary Completion

August 21, 2017

Study Completion

August 21, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations