Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Risk Factor Clinical Trial

— PrevAsPI-Obs  

Official title:

Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108430
• Other study ID #: RNI2016-10
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: April 5, 2017
• Start date: August 22, 2016
• Est. completion date: August 21, 2017

Study information

• Verified date: April 2017
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Jean-Philippe LANOIX, Dr
• Email: lanoix.jean-philippe[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 21, 2017
• Est. primary completion date: August 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Inhalation Pneumonia
• Pneumonia
• Pneumonia, Aspiration
• Respiratory Aspiration
• Risk Factor

Intervention

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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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