ICU's Patients Under Mechanical VentilationPhase 3NCT00219661
Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation
A Phase 3 study testing drainage of subglottic secretions (HiLo Evac tube) in people with ICU's Patients Under Mechanical Ventilation, run by Poissy-Saint Germain Hospital at 4 sites in France.
Trial summary
The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU's Patients Under Mechanical Ventilation
- What is being tested?
- drainage of subglottic secretions (HiLo Evac tube)
- Type of treatment
- Surgery or procedure
- How many people
- 440 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2003to Sep 2006
- Phase
- Phase 3
- 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
- ICU patients expected to require MV more than 48 hours
Who cannot join
- patients already intubated for more than 12 hours
- patients intubated with another tube than the HiLo Evac tube
- patients admitted for cardiac arrest
- patients admitted for self poisoning
- patients admitted with tracheotomy
- patients already included in an another clinical trial
Trial locations and contacts
4 sites in 1 country.
France4 sites
Avignon Hospital
Avignon, 84 000
André Mignot Hospital
Le Chesnay, 78
Poissy Saint-Germain Hospital
Poissy, 78300
Poisyy Saint-Germain Hospital
Saint-Germain-en-Laye, 78
About this study
Official title: Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial
The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.
Read the detailed description
Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.
During the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU's discharge.
Comparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention.
- Being tested
- drainage of subglottic secretions (HiLo Evac tube)
- Keywords
- randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions
- 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.
drainage of subglottic secretions (HiLo Evac tube)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia(VAP)
Secondary outcomes (6)
Duration on mechanical ventilation (MV)
Prior duration of MV before occurrence of VAP
duration of ICU's stay
Rate of tracheotomy
ICU's mortality
Microbiology of the VAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2003
- Study completionSep 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 ICU's Patients Under 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Claude Lacherade, M.D., Principal investigator, Medical Intensive Care Unit, Poissy-Saint-Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219661
- Sponsor's protocol ID
- 323
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 23 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.
PubMed 20522796
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Drainage of Subglottic Secretions on Ventilator-Associated Pneumonia:a Randomised Multicentre Trial
- ClinicalTrials.gov ID
- NCT00219661
- Acronym / sponsor ID
- 323
- Keywords
- randomised control trial, intensive care unit, mechanical ventilation, ventilator-associated pneumonia, drainage of subglottic secretions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Sep 2006 (actual)
- First posted
- 22 Sep 2005 (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 determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.
Detailed description
Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.
During the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU's discharge.
Comparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients expected to require MV more than 48 hours
Key exclusion criteria (6 listed)
- patients already intubated for more than 12 hours
- patients intubated with another tube than the HiLo Evac tube
- patients admitted for cardiac arrest
- patients admitted for self poisoning
- patients admitted with tracheotomy
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 |
|---|---|---|
| drainage of subglottic secretions (HiLo Evac tube) | Procedure or surgery | – |
Primary outcome
Incidence of ventilator-associated pneumonia(VAP)
6 secondary outcomes
Duration on mechanical ventilation (MV)
Prior duration of MV before occurrence of VAP
duration of ICU's stay
Rate of tracheotomy
ICU's mortality
Microbiology of the VAP
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 23 Apr 2007.
- Derived from this study: PubMed 20522796Lacherade JC, De Jonghe B, Guezennec P, Debbat K, Hayon J, Monsel A, Fangio P, Appere de Vecchi C, Ramaut C, Outin H, Bastuji-Garin S. Intermittent subglottic secretion drainage and ventilator-associated pneumonia: a multicenter trial. Am J Respir Crit Care Med. 2010 Oct 1;182(7):910-7. doi: 10.1164/rccm.200906-0838OC. Epub 2010 Jun 3.
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.
Jean-Claude Lacherade, M.D. principal investigator
Medical Intensive Care Unit, Poissy-Saint-Germain Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing drainage of subglottic secretions (HiLo Evac tube) in people with ICU's Patients Under Mechanical Ventilation, run by Poissy-Saint Germain Hospital at 4 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 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 23 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of ventilator-associated pneumonia(VAP). 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 NCT00219661, 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 23 Apr 2007.