Ventilated-acquired PneumoniaNCT01267565
Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
A study testing dosage of amylase in people with Ventilated-acquired Pneumonia, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
Trial summary
Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilated-acquired Pneumonia
- What is being tested?
- dosage of amylase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jun 2012
- Phase
- Interventional
- 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
Who may be able to join
- intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length > 48h and producing sufficient endotracheal aspirations
- non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure
Who cannot join
- patients ventilated for less than 48h
- patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
- paralysed patients
- patients requiring a closed suction device
- patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio < 100, hemorragic risk, brochopleural fistula)
- bronchiectasis, cystic fibrosis
- moribund patient or ethical decision to withhold or withdraw intensive care.
Trial locations and contacts
1 site in 1 country.
About this study
Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.
- Conditions
- Ventilated-acquired Pneumonia
- Being tested
- dosage of amylase
- Keywords
- ventilator-acquired pneumonia, prevention, amylase, tracheal aspiration, microaspiration
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dosage of amylaseOther
4 sets of aspirations on one day per inclusion in the intubated and ventilated patients group and 1 set of aspiration in the non intubated patients group
| Study group | Role | What they receive |
|---|---|---|
| intubated and ventilated patients | Other | patients undergoing mechanical ventilation for an anticipated length of more than 48h Receives: Other: dosage of amylase |
| non intubated patients | Other | non intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure Receives: Other: dosage of amylase |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral/tracheal amylase ratio
Measured: up to 24h after bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilated-acquired PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Boyer, Université Victor Segalen Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267565
- Sponsor's protocol ID
- ABoyer4
- Status last verified
- Jun 2015
- First submitted
- 23 Dec 2010
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT01267565
- Acronym / sponsor ID
- ABoyer4
- Conditions
- Ventilated-acquired Pneumonia
- Keywords
- ventilator-acquired pneumonia, prevention, amylase, tracheal aspiration, microaspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Dec 2010 (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.
Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intubated and ventilated patients | Other | Other: dosage of amylasepatients undergoing mechanical ventilation for an anticipated length of more than 48h |
| non intubated patients | Other | Other: dosage of amylasenon intubated patients with an independant indication of bronchoscopy including an endotracheal aspiration during the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length > 48h and producing sufficient endotracheal aspirations
- non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure
Key exclusion criteria (7 listed)
- patients ventilated for less than 48h
- patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
- paralysed patients
- patients requiring a closed suction device
- patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio < 100, hemorragic risk, brochopleural fistula)
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 |
|---|---|---|
| dosage of amylase4 sets of aspirations on one day per inclusion in the intubated and ventilated patients group and 1 set of aspiration in the non intubated patients group | Other | intubated and ventilated patients, non intubated patients |
Primary outcome
oral/tracheal amylase ratio
Time frame: up to 24h after bronchoscopy
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 10 Jun 2015.
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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?
A study testing dosage of amylase in people with Ventilated-acquired Pneumonia, run by Université Victor Segalen Bordeaux 2 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 7 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 10 Jun 2015. 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?
oral/tracheal amylase ratio (time frame: up to 24h after bronchoscopy). 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 10 Jun 2015.