Mechanical Ventilation ComplicationPhase 4NostenNCT01351259
Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
A Phase 4 study testing Pneumatic device, cylindrical or tapered cuff in people with Mechanical Ventilation Complication and Tracheal Intubation Morbidity, run by University Hospital, Lille at 1 site in France.
Trial summary
Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication, Tracheal Intubation Morbidity
- What is being tested?
- Pneumatic device, cylindrical or tapered cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Sep 2011
- Phase
- Phase 4
- 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
- Patients requiring intubation in the ICU
- Predicted duration of mechanical ventilation > or = 48h
- Age > or = 18 years
Who cannot join
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.
Read the detailed description
Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.
- Being tested
- Pneumatic device, cylindrical or tapered cuff
- Keywords
- Mechanical ventilation, Intubation, Cuff pressure, Microaspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatic device, cylindrical or tapered cuffDevice
Also called Nosten, Kimberly clark, Covidien
Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic device, tapered cuff | Experimental | Intervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff Receives: Device: Pneumatic device, cylindrical or tapered cuff |
| Pneumatic device, cylindrical cuff | Experimental | Continuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes Receives: Device: Pneumatic device, cylindrical or tapered cuff |
| Routine care, tapered cuff | Active comparator | Routine care of cuff pressure using a manometer, tapered polyurethane cuff Receives: Device: Pneumatic device, cylindrical or tapered cuff |
| Routine care, cylindrical cuff | Active comparator | Routine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff Receives: Device: Pneumatic device, cylindrical or tapered cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with underinflation or overinflation of cuff pressure
Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)
Measured: 48 h
Secondary outcomes (3)
Impact of tracheal-cuff shape on variations in cuff pressure
Patients will be intubated with cylindrical or tapered polyurethane cuffed tubes.
Measured: 48 h
Impact of continuous control of cuff pressure on microaspiration of gastric contents
Pepsin will be quantitatively measured in tracheal aspirates of all patients during the 2 24-h periods (with or without the pneumatic device)
Measured: 48 h
Impact of tracheal cuff shape on microaspiration of gastric contents
Pepsin level in tracheal aspirates will be compared between patients intubated with cylindrical polyurethane cuffed-tubes versus those intubated with tapered polyurethane cuffed-tubes
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startFeb 2010
- Primary completionSep 2011
- Study completionSep 2011
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 Mechanical Ventilation ComplicationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad NSEIR, University Hospital, Lille
- Investigators
- Saad NSEIR, MD, Principal investigator, CHU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351259
- Sponsor's protocol ID
- 2009-A00598-49
- Other IDs
- 2009_20/0925
- Acronym
- Nosten
- Status last verified
- Aug 2013
- First submitted
- 9 May 2011
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.
PubMed 24369057
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Control of Polyurethane Tracheal-cuff Pressure: Efficiency of a Pneumatic Device
- ClinicalTrials.gov ID
- NCT01351259
- Acronym / sponsor ID
- Nosten / 2009-A00598-49
- Keywords
- Mechanical ventilation, Intubation, Cuff pressure, Microaspiration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 May 2011 (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.
Underinflation and overinflation of tracheal cuff are common in intubated patients, including those intubated with polyurethane-cuffed tubes. The aim of this study is to determine the efficiency of a pneumatic device in controlling cuff pressure.
Detailed description
Underinflation and overinflation of tracheal cuff are associated with severe complications such as microaspiration of contaminated secretions, and tracheal ischemia. Efficient control of cuff pressure would probably allow reducing complications related to variations in cuff pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pneumatic device, tapered cuff | Experimental | Device: Pneumatic device, cylindrical or tapered cuffIntervention: continuous control of cuff pressure using a pneumatic device, tapered polyurethane cuff |
| Pneumatic device, cylindrical cuff | Experimental | Device: Pneumatic device, cylindrical or tapered cuffContinuous control of cuff pressure using a pneumatic device in patients intubated with cylindrical polyurethane cuffed tracheal tubes |
| Routine care, tapered cuff | Active comparator | Device: Pneumatic device, cylindrical or tapered cuffRoutine care of cuff pressure using a manometer, tapered polyurethane cuff |
| Routine care, cylindrical cuff | Active comparator | Device: Pneumatic device, cylindrical or tapered cuffRoutine care of cuff pressure using a manometer, cylindrical polyurethane tracheal cuff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring intubation in the ICU
- Predicted duration of mechanical ventilation > or = 48h
- Age > or = 18 years
Key exclusion criteria (3 listed)
- Contraindication for semirecumbent position
- Contraindication for enteral nutrition
- Pregnancy
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 |
|---|---|---|
| Pneumatic device, cylindrical or tapered cuffAlso: Nosten, Kimberly clark, CovidienContinuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff | Device | Pneumatic device, cylindrical cuff, Pneumatic device, tapered cuff, Routine care, cylindrical cuff, Routine care, tapered cuff |
Primary outcome
Percentage of patients with underinflation or overinflation of cuff pressure
Time frame: 48 h
Continuous recording of cuff pressure will be performed during 2 24-h periods (with or without the pneumatic device)
3 secondary outcomes
Impact of tracheal-cuff shape on variations in cuff pressure
Time frame: 48 h
Impact of continuous control of cuff pressure on microaspiration of gastric contents
Time frame: 48 h
Impact of tracheal cuff shape on microaspiration of gastric contents
Time frame: 48 h
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 4 Sep 2013.
- Derived from this study: PubMed 24369057Jaillette E, Zerimech F, De Jonckheere J, Makris D, Balduyck M, Durocher A, Duhamel A, Nseir S. Efficiency of a pneumatic device in controlling cuff pressure of polyurethane-cuffed tracheal tubes: a randomized controlled study. BMC Anesthesiol. 2013 Dec 26;13(1):50. doi: 10.1186/1471-2253-13-50.
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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 principal investigator
CHU de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumatic device, cylindrical or tapered cuff in people with Mechanical Ventilation Complication and Tracheal Intubation Morbidity, run by University Hospital, Lille 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 3 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 4 Sep 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of patients with underinflation or overinflation of cuff pressure (time frame: 48 h). 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 NCT01351259, 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 4 Sep 2013.