Critical IllnessBestCuffNCT01948635
Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
A study testing tapered PVC-cuffed tracheal tubes and Standard PVC-cuffed tracheal tube in people with Critical Illness and Mechanical Ventilation Complication, run by University Hospital, Lille at 9 sites in France.
Trial summary
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation Complication, Ventilator Associated Pneumonia
- What is being tested?
- tapered PVC-cuffed tracheal tubes and Standard PVC-cuffed tracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 9 sitesFrance
- Study dates
- Apr 2014to Aug 2015
- 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
- age > or = 18 years
- tracheal intubation
- predictable duration of mechanical ventilation > 48h
- enteral nutrition
Who cannot join
- pregnant women
- refuse to participate to the study
- no informed consent
- contre indication for semirecumbent position
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
centre Hospitalier
Boulogne-sur-Mer
Centre Hospitalier
Dunkirk
Centre Hospitalier
Lens
ICU, Salengro Hospital, University Hospital of Lille
Lille, Nord, 59035
Centre Hospitalier St Philibert
Lomme
Centre hospitalier
Roubaix
Centre Hospitalier Universitaire
Rouen
Centre Hospitalie
Tourcoing
Centre Hospitalier
Valenciennes
About this study
The investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
Read the detailed description
Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.
Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.
- Being tested
- tapered PVC-cuffed tracheal tubes, Standard PVC-cuffed tracheal tube
- Keywords
- tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia
- Medical subject headings
- Critical Illness, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tapered PVC-cuffed tracheal tubesDevice
Patients will be intubated with tapered-shape tracheal tubes
Standard PVC-cuffed tracheal tubeDevice
Patients will be intubated with standard PVC cuffed tracheal tubes
| Study group | Role | What they receive |
|---|---|---|
| tapered PVC-cuffed tracheal tubes | Experimental | Patients in this arm will be intubated with tapered PVC-tracheal tubes Receives: Device: tapered PVC-cuffed tracheal tubes |
| Standard PVC-cuffed tracheal tube | Active comparator | Patients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes Receives: Device: Standard PVC-cuffed tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microaspiration of gastric contents
Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents
Measured: 48 hours after randomization
Secondary outcomes (3)
Microaspiration of oropharyngeal secretions
amylase level on tracheal aspirate would allow to quantify microaspiration of oropharyngeal secretions
Measured: 48 h after randomization
Tracheobronchial colonization
Measured: 28 days after randomization
Ventilator-associated pneumonia
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Nseir, MD, PhD, Principal investigator, CHRU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948635
- Sponsor's protocol ID
- 2012_45
- Other IDs
- 2013 A00534 41, PHRCI_2012
- Acronym
- BestCuff
- Status last verified
- May 2018
- First submitted
- 31 Aug 2013
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.
PubMed 26407612Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.
PubMed 28303301Millot G, Behal H, Jaillette E, Girault C, Brunin G, Labreuche J, Alves I, Minacori F, Georges H, Herbecq P, Fayolle C, Maboudou P, Zerimech F, Balduyck M, Nseir S. Relationship between microaspiration and ventilator-associated events: A post-hoc analysis of a randomized controlled trial. Intensive Crit Care Nurs. 2025 Feb;86:103778. doi: 10.1016/j.iccn.2024.103778. Epub 2024 Jul 27.
PubMed 39068123
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Tracheal Cuff Shape on Microaspiration in Intensive Care Units
- ClinicalTrials.gov ID
- NCT01948635
- Acronym / sponsor ID
- BestCuff / 2012_45
- Keywords
- tracheal cuff shape, microaspiration, pepsin, ventilator-associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Sep 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 investigators hypothesized that PVC tapered-cuff tracheal tubes would reduce microaspiration of gastric content as determined by pepsin level in tracheal aspirate.
Detailed description
Microaspiration is the main route for entry of contaminated secretions into the lower respiratory tract of intubated critically ill patients. Tracheobronchial colonization might progress to ventilator-associated pneumonia (VAP) when the quantity and virulence of bacteria are high and when local and general host defenses are weak.
Recent in vitro and animal studies suggest that tapered-cuff tracheal tubes could be associated with reduced microaspiration of contaminated secretions and might be helpful in preventing VAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tapered PVC-cuffed tracheal tubes | Experimental | Device: tapered PVC-cuffed tracheal tubesPatients in this arm will be intubated with tapered PVC-tracheal tubes |
| Standard PVC-cuffed tracheal tube | Active comparator | Device: Standard PVC-cuffed tracheal tubePatients in this arm will be intubated with standard (barrel-shape cuffed) PVC tracheal tubes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age > or = 18 years
- tracheal intubation
- predictable duration of mechanical ventilation > 48h
- enteral nutrition
Key exclusion criteria (4 listed)
- pregnant women
- refuse to participate to the study
- no informed consent
- contre indication for semirecumbent position
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 |
|---|---|---|
| tapered PVC-cuffed tracheal tubesPatients will be intubated with tapered-shape tracheal tubes | Device | tapered PVC-cuffed tracheal tubes |
| Standard PVC-cuffed tracheal tubePatients will be intubated with standard PVC cuffed tracheal tubes | Device | Standard PVC-cuffed tracheal tube |
Primary outcome
Microaspiration of gastric contents
Time frame: 48 hours after randomization
Mesuerment of pepsin level in tracheal aspirate will be used to quantify microaspiration of gastric contents
3 secondary outcomes
Microaspiration of oropharyngeal secretions
Time frame: 48 h after randomization
Tracheobronchial colonization
Time frame: 28 days after randomization
Ventilator-associated pneumonia
Time frame: 28 days after randomization
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 22 Dec 2025.
- Background: PubMed 26407612Jaillette E, Brunin G, Girault C, Zerimech F, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S. Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:429. doi: 10.1186/s13063-015-0955-z.
- Results publication: PubMed 28303301Jaillette E, Girault C, Brunin G, Zerimech F, Behal H, Chiche A, Broucqsault-Dedrie C, Fayolle C, Minacori F, Alves I, Barrailler S, Labreuche J, Robriquet L, Tamion F, Delaporte E, Thellier D, Delcourte C, Duhamel A, Nseir S; BestCuff Study Group and the BoReal Network. Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial. Intensive Care Med. 2017 Nov;43(11):1562-1571. doi: 10.1007/s00134-017-4736-x. Epub 2017 Mar 16.
- Derived from this study: PubMed 39068123Millot G, Behal H, Jaillette E, Girault C, Brunin G, Labreuche J, Alves I, Minacori F, Georges H, Herbecq P, Fayolle C, Maboudou P, Zerimech F, Balduyck M, Nseir S. Relationship between microaspiration and ventilator-associated events: A post-hoc analysis of a randomized controlled trial. Intensive Crit Care Nurs. 2025 Feb;86:103778. doi: 10.1016/j.iccn.2024.103778. Epub 2024 Jul 27.
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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.
Saad Nseir, MD, PhD principal investigator
CHRU de Lille
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tapered PVC-cuffed tracheal tubes and Standard PVC-cuffed tracheal tube in people with Critical Illness and Mechanical Ventilation Complication, run by University Hospital, Lille at 9 sites 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 4 inclusion and 4 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Microaspiration of gastric contents (time frame: 48 hours after randomization). 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 NCT01948635, which also lists 3 linked publications.
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 22 Dec 2025.