ICU PatientsSPIRENCT01881672
Syndrome and Aspiration Pneumonia in Intensive Care
An observational study of ICU Patients and Under Mechanical Ventilation, run by Centre Hospitalier Departemental Vendee at 1 site in France.
Trial summary
Inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Patients, Under Mechanical Ventilation, In State of Coma (Define by Glasgow ≤ 8)
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in ICU for coma (define by Glasgow score < 8) and under mechanical ventilation. Suspicion of bacterial inhalation pneumonia will be confirme by a protected distal sampling during a flexible bronchoscopy.
Who may be able to join
- Altered consciousness defined by a Glasgow Coma Scale score less than or equal to 8 before protection of the upper airway by endotracheal intubation
- Patient under mechanical ventilation
Who cannot join
- Patient with pre-existing impairment of laryngeal function in Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, laryngeal cancer, radiotherapy laryngeal
- Patient under guardianship
- Inpatient without consent
- Pregnant woman
- Patient previously treated with antibiotics for more than 24 hours at the time of ICU admission
- Patient with infection at ICU admission which justified probabilist antibiotic treatment
- Lack of social security
- Refusal of the patient or their next of kind
Trial locations and contacts
1 site in 1 country.
About this study
Inhalation is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of ICU stay increased. However, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known.
The aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
- Conditions
- ICU Patients, Under Mechanical Ventilation, In State of Coma (Define by Glasgow ≤ 8), No Antibiotic Treatment
- Keywords
- Aspiration pneumonia, Coma, Mechanical ventilation
- Medical subject headings
- Pneumonia, Aspiration, Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Coma patients in ICU under mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
Participants will be followed for the duration of ICU stay, an expected average of 4 days
Measured: ICU Discharge
Secondary outcomes (3)
Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation
Participants will be followed for the duration of ICU stay, an expected average of 4 days
Measured: ICU Discharge
Description of the bacterial flora identified in respiratory specimens.
Participants will be followed for the duration of ICU stay, an expected average of 4 days
Measured: ICU Discharge
Identification of predictive factors for development of bacterial pneumonia
Participants will be followed for the duration of ICU stay, an expected average of 4 days
Measured: ICU Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU PatientsStudies of the same condition, open and under way.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Baptiste Lascarrou, MD, Principal investigator, CHD Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881672
- Sponsor's protocol ID
- SPIRE
- Acronym
- SPIRE
- Status last verified
- Aug 2016
- First submitted
- 13 Jun 2013
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome and Aspiration Pneumonia in Intensive Care
- ClinicalTrials.gov ID
- NCT01881672
- Acronym / sponsor ID
- SPIRE / SPIRE
- Conditions
- ICU Patients, Under Mechanical Ventilation, In State of Coma (Define by Glasgow ≤ 8), No Antibiotic Treatment
- Keywords
- Aspiration pneumonia, Coma, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Jun 2013 (estimated)
- 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 is a common condition in patients with impaired their awareness requiring protection of the upper airway by endotracheal intubation. This inhalation may lead to chemical pneumonitis and/or bacterial pneumonia. Only the latter requires the administration of antibiotics. Patients developing such a bacterial pneumonia, has a mortality, duration of mechanical ventilation and length of ICU stay increased. However, the proportion of patients with such bacterial pneumonia, bacterial ecology and morbidity that are little known.
The aim of this study is to determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coma patients in ICU under mechanical ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in ICU for coma (define by Glasgow score < 8) and under mechanical ventilation. Suspicion of bacterial inhalation pneumonia will be confirme by a protected distal sampling during a flexible bronchoscopy.
Key inclusion criteria (2 listed)
- Altered consciousness defined by a Glasgow Coma Scale score less than or equal to 8 before protection of the upper airway by endotracheal intubation
- Patient under mechanical ventilation
Key exclusion criteria (8 listed)
- Patient with pre-existing impairment of laryngeal function in Parkinson's disease, Alzheimer's disease, amyotrophic lateral sclerosis, laryngeal cancer, radiotherapy laryngeal
- Patient under guardianship
- Inpatient without consent
- Pregnant woman
- Patient previously treated with antibiotics for more than 24 hours at the time of ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation
Time frame: ICU Discharge
Participants will be followed for the duration of ICU stay, an expected average of 4 days
3 secondary outcomes
Quantify the use of antibiotics during the ICU stay for patients admitted to the ICU for coma and treated with mechanical ventilation
Time frame: ICU Discharge
Description of the bacterial flora identified in respiratory specimens.
Time frame: ICU Discharge
Identification of predictive factors for development of bacterial pneumonia
Time frame: ICU Discharge
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 26 Aug 2016.
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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.
Jean Baptiste Lascarrou, MD principal investigator
CHD Vendee
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 ICU Patients and Under Mechanical Ventilation, run by Centre Hospitalier Departemental Vendee 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 2 inclusion and 8 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 26 Aug 2016. 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?
Determine the frequency of bacterial pneumonia in patients admitted to the ICU for coma and treated with mechanical ventilation (time frame: ICU Discharge). 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 26 Aug 2016.