- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439146
Risk of Pneumonia in Intubated Patients in Emergency Situations (PNEUMIOT)
Orotracheal intubation in emergency medicine is a vital procedure for ensuring adequate oxygenation and ventilation in patients with respiratory distress or in shock. However, this procedure exposes patients to complications such as pneumonia. In the matter of fact, the urgency of the procedure means that it is not possible to wait until the patient's stomach is empty. Pneumonia significantly increase patient morbidity and mortality. Therapeutic management must be early and appropriate to improve the patient's prognosis.
The aim of this study is to compare the rate of pneumonia occurring in patients intubated in emergency situations with that in patients intubated in non-emergency situations in all 2024. Health data will only collected from patient's medical records.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Phone Number: 334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
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Aurillac, France, 15000
- CH Aurillac
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Contact:
- Jonathan DUCHENNE
- Phone Number: 0471468241
- Email: j.duchenne@ch-aurillac.fr
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Principal Investigator:
- Jonathan DUCHENNE
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Clermont-Ferrand, France
- CHU de Clermont-Ferrand, Clermont-Ferrand
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Contact:
- Lise Laclautre
- Phone Number: 334.73.754.963
- Email: promo_interne_drci@chu-clermontferrand.fr
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Principal Investigator:
- Jean-Bpatiste BOUILLON-MINOIS
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Le Puy-en-Velay, France, 43000
- CH du Puy en Velay
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Contact:
- Adrien ROBERT
- Phone Number: No phone number
- Email: adrien.robert@ch-lepuy.fr
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Principal Investigator:
- Adrien ROBERT
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Sub-Investigator:
- Angelo Giordano KWAKYE AGYEMANG
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Montluçon, France, 03100
- CH de Montluçon
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Contact:
- Sébastien LOISEAU
- Phone Number: 0470027210
- Email: s.loiseau@ch-montlucon.fr
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Principal Investigator:
- Sébastien LOISEAU
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Moulins, France, 03000
- CH de Moulins
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Principal Investigator:
- Fabien THOMAS
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Contact:
- Fabien THOMAS
- Phone Number: No phone number
- Email: f.thomas@ch-moulins-yzeure.fr
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Vichy, France, 03200
- CH de Vichy
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Contact:
- Gaël GIBOT
- Phone Number: No phone number
- Email: gael.gibot@ch-vichy.fr
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Principal Investigator:
- Gaël GIBOT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult man or woman
- Emergency and non-emergency intubated patient in 2024
- Patient hospitalized in intensive care following intubation in 2024
Exclusion Criteria:
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant woman
- Refusal to participate
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Intubated patients in emergency situations
Health data will be collected only with medical's record of intubated patients in emergency situation in 2024.
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Intubated patients in non emergency situations
Health data will be collected only with medical's record of intubated patients in non emergency situation in 2024.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pneumonia rate in 48 hours after the start of orotracheal intubation.
Time Frame: Hour 48
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Rate of pneumonia occuring within 48 hours of the start of orotracheal intubation.
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Hour 48
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pneumonia rate occuring 48 hours after the start of orotracheal intubation.
Time Frame: 3 months
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Rate of pneumonia occuring more than 48 hours after the start of orotracheal intubation.
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3 months
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Duration of mechanical ventilation
Time Frame: Up to the end of mechanical ventilation (assessed up to 1 month)
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Duration of mechanical ventilation
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Up to the end of mechanical ventilation (assessed up to 1 month)
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Duration of stay in intensive care
Time Frame: Up to intensive care discharge (assessed up to 1 month)
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Duration of stay in intensive care
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Up to intensive care discharge (assessed up to 1 month)
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Duration of hospital stay
Time Frame: Up to hospital discharge (assessed up to 3 months)
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Duration of hospital stay
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Up to hospital discharge (assessed up to 3 months)
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Mortality rate
Time Frame: Inclusion + 1 year
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Mortality rate
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Inclusion + 1 year
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Type of bacteria responsible for pneumonia
Time Frame: The day of the diagnosis of pneumonia (assessed up to 1 month)
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The bacterial species responsible for pneumonia will be identified using biological samples (blood, urine, bronchial secretions) taken from patients in both groups.
The identification of bacterial species will be carried out in the laboratory.
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The day of the diagnosis of pneumonia (assessed up to 1 month)
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Type of antibiotic administered for pneumonia
Time Frame: Up to the last day of antibiotic treatment (assessed up to 3 months)
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Type of antibiotic administered for pneumonia in each group
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Up to the last day of antibiotic treatment (assessed up to 3 months)
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Antibiotic doses administered for pneumonia
Time Frame: Up to the last day of antibiotic treatment (assessed up to 3 months)
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Comparison of antibiotic doses in g or mg administered in each group
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Up to the last day of antibiotic treatment (assessed up to 3 months)
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Duration of antibiotic treament for pneumonia
Time Frame: Up to the last day of antibiotic treatment (assessed up to 3 months)
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Duration of antibiotic treament for pneumonia in each group
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Up to the last day of antibiotic treatment (assessed up to 3 months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Baptiste BOUILLON-MINOIS, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025_BOUILLON MINOIS_Pneumiot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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