Inhalation PneumoniaPrevAsPI-ObsNCT03108430
Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation
An observational study of Inhalation Pneumonia and Risk Factor, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inhalation Pneumonia, Risk Factor
- What is being tested?
- Risk factors and incidence of IP after inhalation
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2016to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Observation of inhalations in medicine and resuscitation and collection of data likely to influence the emergence of an IP.
Who may be able to join
- 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
Who cannot join
- Patients with VAP
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Inhalation Pneumonia, Risk Factor
- Being tested
- Risk factors and incidence of IP after inhalation
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk factors and incidence of IP after inhalationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhalation pneumonia | Not described Receives: Other: Risk factors and incidence of IP after inhalation | |
| Proven inhalations | Not described Receives: Other: Risk factors and incidence of IP after inhalation | |
| Suspected inhalations (coma + anamnesis) | Not described Receives: Other: Risk factors and incidence of IP after inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start18 Nov 2016
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inhalation PneumoniaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108430
- Sponsor's protocol ID
- RNI2016-10
- Acronym
- PrevAsPI-Obs
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2017
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Risk Factors for Developing Inhalation Pneumonia After Inhalation
- ClinicalTrials.gov ID
- NCT03108430
- Acronym / sponsor ID
- PrevAsPI-Obs / RNI2016-10
- Conditions
- Inhalation Pneumonia, Risk Factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Observation of inhalations in medicine and resuscitation and collection of data likely to influence the emergence of an IP.
Key inclusion criteria (7 listed)
- 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 :
Key exclusion criteria (1 listed)
- Patients with VAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk factors and incidence of IP after inhalationCalculate 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. | Other | Inhalation pneumonia, Proven inhalations, Suspected inhalations (coma + anamnesis) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inhalation Pneumonia and Risk Factor, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.