Mechanical VentilationPhase 4A/NNCT00475579
Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage
A Phase 4 study testing tube with subglottic drainage and polyurethane cuff in people with Mechanical Ventilation, run by Hospital Universitario de Canarias.
Trial summary
Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- tube with subglottic drainage and polyurethane cuff
- Type of treatment
- Surgery or procedure
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Oct 2006
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients expected to require mechanical ventilation for more than 24 hours
Who cannot join
- Age <18 years,
- Pregnancy,
- HIV,
- Blood leukocytes counts <1000 cells/mm3,
- Solid or haematological tumour,
- Immunosuppressive therapy
About this study
Official title: Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia
Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube
Read the detailed description
Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.
- Conditions
- Mechanical Ventilation
- Being tested
- tube with subglottic drainage and polyurethane cuff
- Keywords
- ventilator-associated pneumonia, endotracheal tube, polyurethane cuff, polyvinyl cuff, subglottic secretion drainage
- 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.
tube with subglottic drainage and polyurethane cuffProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-associated pneumonia
Measured: 8 months
Secondary outcomes (1)
Late-onset ventilator-associated pneumonia
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMar 2006
- Study completionOct 2006
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 VentilationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Investigators
- Leonardo Lorente, MD, PhD, Principal investigator, Intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475579
- Sponsor's protocol ID
- 01/03/2006
- Acronym
- A/N
- Status last verified
- May 2007
- First submitted
- 17 May 2007
- Last updated
- 21 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lorente L, Lecuona M, Jimenez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.
PubMed 17872488
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT00475579
- Acronym / sponsor ID
- A/N / 01/03/2006
- Conditions
- Mechanical Ventilation
- Keywords
- ventilator-associated pneumonia, endotracheal tube, polyurethane cuff, polyvinyl cuff, subglottic secretion drainage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Oct 2006 (actual)
- First posted
- 21 May 2007 (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.
Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube
Detailed description
Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients expected to require mechanical ventilation for more than 24 hours
Key exclusion criteria (6 listed)
- Age <18 years,
- Pregnancy,
- HIV,
- Blood leukocytes counts <1000 cells/mm3,
- Solid or haematological tumour,
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 |
|---|---|---|
| tube with subglottic drainage and polyurethane cuff | Procedure or surgery | – |
Primary outcome
Ventilator-associated pneumonia
Time frame: 8 months
1 secondary outcome
Late-onset ventilator-associated pneumonia
Time frame: 8 months
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 21 May 2007.
- Derived from this study: PubMed 17872488Lorente L, Lecuona M, Jimenez A, Mora ML, Sierra A. Influence of an endotracheal tube with polyurethane cuff and subglottic secretion drainage on pneumonia. Am J Respir Crit Care Med. 2007 Dec 1;176(11):1079-83. doi: 10.1164/rccm.200705-761OC. Epub 2007 Sep 13.
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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.
Leonardo Lorente, MD, PhD principal investigator
Intensive care unit
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tube with subglottic drainage and polyurethane cuff in people with Mechanical Ventilation, run by Hospital Universitario de Canarias.
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 1 inclusion and 6 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 21 May 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
Ventilator-associated pneumonia (time frame: 8 months). 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 NCT00475579, 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 21 May 2007.