Ventilator Acquired PneumoniaAMYLASPINCT01807884
Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients
A study testing Optimized oral care and Routine oral care in people with Ventilator Acquired Pneumonia and Aspiration, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Acquired Pneumonia, Aspiration
- What is being tested?
- Optimized oral care and Routine oral care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2014to 4 Mar 2016
- 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 with a subglottic secretion drainage device
- ventilated more than 48 hours
- patients yielding a significant tracheal suctioning volume (on a semi-qualitative evaluation: ≥ ++ on a scale consisting of 0,+,++,+++)
Who cannot join
- paralysed patients
- patients with Ramsay 1, 2
- patients breathing spontaneously
- patients less than 18 years old
- patients in a moribund state
- contra-indication for suctioning procedure (risk of haemorrhage, bronchospasm, Acute Respiratory Distress Syndrome with P/F < 100, malformation or tracheal fistula)
Show all 9Show fewer
- bronchiectasis, cystic fibrosis, chronic obstructive pulmonary disease
- patients necessitating a closed-suctioning device (prevention of respiratory multiresistant bacteria transmission, Acute Respiratory Distress Syndrome with P/F ratio < 100)
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients: a Pilot Trial
The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.
Read the detailed description
- Study design : This is an open prospective, cross-over cohort study, including patients ventilated in one medical intensive care unit. Two procedures will be compared in two distinct, randomly decided cross-over consecutive periods
- Detailed description : Standard cares include tracheal suctions several times a day. They can induce a cough reflex in non paralysed patients leading to the mobilisation of the endotracheal tube and a consecutive raise in the risk of tracheal microaspiration. Thus drainage of subglottic secretion before tracheal suction is expected to reduce microaspiration. Subglottic secretion drainage could decrease the risk of Ventilator Associated Pneumonia even if it remains to be confirmed. However, no study assessed its efficiency in reducing tracheal microaspiration.
An optimization of the oropharyngeal suction procedure will include the use of a subglottic drainage in a specified order to realize a so called "optimized oral care". A comparison will be done with a routine oral care.
We will conduct a crossover study in which the patient's follow-up will last 2 days. Length of suction procedure and mouth care, volume of oral, subglottic and tracheal secretions and their qualitative appearance will be collected. The amylase enzymatic activity will be assessed in oropharyngeal, subglottic and tracheal samples.
- Registry procedure : All requested information will be recorded on case report forms and explanation will be reported for any missing data. False data will be clearly corrected, and signed by investigator or authorised person. For biochemical data (amylase enzymatic activity), results will be transmitted through excel software via a key and data will be integrated to the principal excel file on professional computer of the investigator.
Monitoring will be realised by the co-investigator in association with the clinical research associate.
- Quality factors. This clinical research associates will regularly check data to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry and a report will be report after each checking.
- Sample size assessment: Number of subjects : 24 patients. Six months should be necessary to include these patients.
- Statistical analysis : The sample size estimate assumed a median ratio of 8% and an estimated reduction from 8 to 2% with the optimized oral care. We determined that 12 patients per group would provide a power of 80%, with an α level of 5%.
Results will be expressed as means ± Standard Deviation. Continuous variables will be compared using the Student's t-test for matched paired series and categorical variables using the Chi 2 test. All p values and confidence intervals will be two-tailed. p<0.05 will be considered to be statistically significant.
- Conditions
- Ventilator Acquired Pneumonia, Aspiration
- Being tested
- Optimized oral care, Routine oral care
- Keywords
- Microaspiration, Ventilator acquired Pneumonia, Amylase, Mechanical ventilation, Suction
- 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.
Optimized oral careProcedure or surgery
An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction
Routine oral careOther
Oral suction followed by mouth care and tracheal suction without any subglottic suction
| Study group | Role | What they receive |
|---|---|---|
| Optimized oral care | Experimental | An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction Receives: Procedure: Optimized oral care |
| Routine oral care | Placebo comparator | Oral suction followed by mouth care and tracheal suction Receives: Other: Routine oral care |
What is being measured
The primary outcome is the main question the study is designed to answer.
tracheal to oropharyngeal ratio of amylase enzymatic activity
As a surrogate for microaspiration, the tracheal to oropharyngeal ratio of amylase enzymatic activity will be assessed after oral care. A mean of measures realized one day after optimized oral care will be compared to a mean of measure realized the other day after standard oral care as a cross over protocol.
Measured: Day 1 and Day 2
Secondary outcomes (3)
volume of the tracheal, subglottic, and oral suctions
qualitative evaluation of volume of the tracheal, oral and when applicable subglottic suctions
Measured: three time a day, during 2 days
length of each mouth care
Length in minutes of each mouth care, including tracheal, oral and when applicable subglottic, suctions
Measured: three time a day, during 2 days
cost of the optimized oral suctioning compared with routine care
Mean cost of needed material and timed spented by nurses for each mouth care
Measured: At the end of the period of study (48hours) for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study start12 Nov 2014
- Primary completion4 Mar 2016
- Study completion4 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Teleflex
- Responsible party
- Sponsor
- Investigators
- Alexandre Boyer, MD, Principal investigator, Université Victor Segalen Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807884
- Sponsor's protocol ID
- AMYLASPI
- Other IDs
- 2013-A00835-40
- Acronym
- AMYLASPI
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2013
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Griton M, Naud N, Gruson D, Bedel A, Boyer A. The risk of microaspiration during oral care in mechanically ventilated patients: A randomised cross-over study comparing two different suction protocols. Intensive Crit Care Nurs. 2021 Apr;63:102965. doi: 10.1016/j.iccn.2020.102965. Epub 2020 Nov 10.
PubMed 33183954
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients: a Pilot Trial
- ClinicalTrials.gov ID
- NCT01807884
- Acronym / sponsor ID
- AMYLASPI / AMYLASPI
- Conditions
- Ventilator Acquired Pneumonia, Aspiration
- Keywords
- Microaspiration, Ventilator acquired Pneumonia, Amylase, Mechanical ventilation, Suction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Teleflex
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 4 Mar 2016 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 8 Mar 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.
The purpose of this study is to evaluate the impact of an optimized suctioning procedure on the risk of endotracheal microaspiration, measured by tracheal to oropharyngeal ratio of amylase enzymatic activity.
Detailed description
- Study design : This is an open prospective, cross-over cohort study, including patients ventilated in one medical intensive care unit. Two procedures will be compared in two distinct, randomly decided cross-over consecutive periods
- Detailed description : Standard cares include tracheal suctions several times a day. They can induce a cough reflex in non paralysed patients leading to the mobilisation of the endotracheal tube and a consecutive raise in the risk of tracheal microaspiration. Thus drainage of subglottic secretion before tracheal suction is expected to reduce microaspiration. Subglottic secretion drainage could decrease the risk of Ventilator Associated Pneumonia even if it remains to be confirmed. However, no study assessed its efficiency in reducing tracheal microaspiration.
An optimization of the oropharyngeal suction procedure will include the use of a subglottic drainage in a specified order to realize a so called "optimized oral care". A comparison will be done with a routine oral care.
We will conduct a crossover study in which the patient's follow-up will last 2 days. Length of suction procedure and mouth care, volume of oral, subglottic and tracheal secretions and their qualitative appearance will be collected. The amylase enzymatic activity will be assessed in oropharyngeal, subglottic and tracheal samples.
- Registry procedure : All requested information will be recorded on case report forms and explanation will be reported for any missing data. False data will be clearly corrected, and signed by investigator or authorised person. For biochemical data (amylase enzymatic activity), results will be transmitted through excel software via a key and data will be integrated to the principal excel file on professional computer of the investigator.
Monitoring will be realised by the co-investigator in association with the clinical research associate.
- Quality factors. This clinical research associates will regularly check data to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry and a report will be report after each checking.
- Sample size assessment: Number of subjects : 24 patients. Six months should be necessary to include these patients.
- Statistical analysis : The sample size estimate assumed a median ratio of 8% and an estimated reduction from 8 to 2% with the optimized oral care. We determined that 12 patients per group would provide a power of 80%, with an α level of 5%.
Results will be expressed as means ± Standard Deviation. Continuous variables will be compared using the Student's t-test for matched paired series and categorical variables using the Chi 2 test. All p values and confidence intervals will be two-tailed. p<0.05 will be considered to be statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized oral care | Experimental | Procedure: Optimized oral careAn optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction |
| Routine oral care | Placebo comparator | Other: Routine oral careOral suction followed by mouth care and tracheal suction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated with a subglottic secretion drainage device
- ventilated more than 48 hours
- patients yielding a significant tracheal suctioning volume (on a semi-qualitative evaluation: ≥ ++ on a scale consisting of 0,+,++,+++)
Key exclusion criteria (9 listed)
- paralysed patients
- patients with Ramsay 1, 2
- patients breathing spontaneously
- patients less than 18 years old
- patients in a moribund state
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 |
|---|---|---|
| Optimized oral careAn optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction | Procedure or surgery | Optimized oral care |
| Routine oral careOral suction followed by mouth care and tracheal suction without any subglottic suction | Other | Routine oral care |
Primary outcome
tracheal to oropharyngeal ratio of amylase enzymatic activity
Time frame: Day 1 and Day 2
As a surrogate for microaspiration, the tracheal to oropharyngeal ratio of amylase enzymatic activity will be assessed after oral care. A mean of measures realized one day after optimized oral care will be compared to a mean of measure realized the other day after standard oral care as a cross over protocol.
3 secondary outcomes
volume of the tracheal, subglottic, and oral suctions
Time frame: three time a day, during 2 days
length of each mouth care
Time frame: three time a day, during 2 days
cost of the optimized oral suctioning compared with routine care
Time frame: At the end of the period of study (48hours) for each patient
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 17 Sep 2026.
- Results publication: PubMed 33183954Griton M, Naud N, Gruson D, Bedel A, Boyer A. The risk of microaspiration during oral care in mechanically ventilated patients: A randomised cross-over study comparing two different suction protocols. Intensive Crit Care Nurs. 2021 Apr;63:102965. doi: 10.1016/j.iccn.2020.102965. Epub 2020 Nov 10.
- Individual participant dataSharing planned: No
Related trials for Ventilator Acquired Pneumonia
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruiting
Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Alexandre Boyer, MD principal investigator
Université Victor Segalen Bordeaux 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized oral care and Routine oral care in people with Ventilator Acquired Pneumonia and Aspiration, run by University Hospital, Bordeaux 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 3 inclusion and 9 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 17 Sep 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. Some participants in this study may receive a placebo. 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?
tracheal to oropharyngeal ratio of amylase enzymatic activity (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807884, which also lists 1 linked publication.
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 17 Sep 2026.