InfectionPhase 2NCT00341354
Coated Endotracheal Tube and Mucus Shaver to Prevent Hospital-Acquired Infections
A Phase 2 study testing Prolonged Mechanical Ventilation in people with Infection, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in Italy.
Trial summary
This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus Shaver is safe and effective in preventing hospital-acquired infections in patients who require prolonged mechanical ventilation in an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Prolonged Mechanical Ventilation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2006to 6 Sep 2007
- Phase
- Phase 2
- 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
- Males and females greater than 18 years old;
- Patients who are expected to be intubated and mechanically ventilated for greater than 48 hours;
- Patients who require an endotracheal tube with an internal diameter of 7.5 mm or 8.0 mm.
Who cannot join
- Males and females less than 18 years old;
- Patients who are expected to be intubated for less than 48 hours;
- Patients who are allergic to silver-sulfadiazine;
- Patients who require an internal diameter of an endotracheal tube less than 7.5 mm or greater than 8.0 mm;
- Patients who do not tolerate disconnection from the ventilator:
- Hemodynamically unstable;
- Severe ARDS: PaO2/FiO2 less than or equal to 200 at PEEP less than or equal to 5 cmH20.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Silver-Sulfadiazine Tracheal Tubes / Mucus Shaver in Intubated Patients Expected to Have a Prolonged Mechanical Ventilation
This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus Shaver is safe and effective in preventing hospital-acquired infections in patients who require prolonged mechanical ventilation in an intensive care unit (ICU).
Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is likely related to the use of a breathing tube. The tube is placed in the patient's trachea (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in intubated patients are cleaned with a suction catheter that draws out secretions that accumulate in the tube. This method does not clean the tube completely, however, and within a few hours after the breathing tube is placed, bacteria may begin to grow inside the tube. Over time, as the patient breathes in and out through the tube, the bacteria may break free and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the tube decreases the size of the airway passage, making it more difficult to keep air moving in and out of the lungs.
Read more
Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented bacterial growth in the patient's airways and that use of the Mucus Shaver prevented accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This study will determine if use of the coated tube and Mucus Shaver in patients requiring prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in ICU and hospital.
Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible for this study.
Participants are randomly assigned to have either a standard breathing tube and standard cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of the breathing tube is then cultured every day. When the tube is removed, or on the eighth day of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. After the tube is removed, it is examined for biological and microscopic analysis.
Read the detailed description
Pneumonia is the most frequent hospital-acquired infection in the intensive care unit, having a significant mortality, morbidity and cost. It occurs frequently in patients who are intubated and on a ventilator. In two phase I/II clinical studies, we tested endotracheal tubes (ETT), internally coated with bacteriocidal agents, and the Mucus Shaver, which removes material from the inside of the endotracheal tube. We showed 1) no adverse events, 2) that coating the inner wall of the ETT with silver-sulfadiazine significantly reduced bacterial colonization of the ETT; and 3) the Mucus Shaver cleans the lumen, leaving the entire endotracheal tube free of secretions, and maintains the lumen diameter. In this study, to evaluate the safety and effectiveness of the Mucus Shaver with the coated ETT, we propose to conduct a randomized trial in intubated patients on prolonged mechanical ventilation.
- Conditions
- Infection
- Being tested
- Prolonged Mechanical Ventilation
- Keywords
- Pneumonia, Bacterial Infection, Nosocomial Infection, Trachea, Biofilm, Mucus Shaver
- Medical subject headings
- Infections, Pneumonia, Bacterial Infections, Cross Infection, Tracheal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Mechanical VentilationBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start27 Jan 2006
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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 2
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341354
- Sponsor's protocol ID
- 999906087
- Other IDs
- 06-H-N087
- Status last verified
- 6 Sep 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Silver-Sulfadiazine Tracheal Tubes / Mucus Shaver in Intubated Patients Expected to Have a Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00341354
- Acronym / sponsor ID
- 999906087
- Conditions
- Infection
- Keywords
- Pneumonia, Bacterial Infection, Nosocomial Infection, Trachea, Biofilm, Mucus Shaver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 27 Jan 2006
- Study completion
- 6 Sep 2007
- First posted
- 21 Jun 2006 (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.
This study, conducted at the San Gerardo Hospital in Milan, Italy, will examine whether a bacteriocidal-coated endotracheal tube (breathing tube) cleaned with a device called a Mucus Shaver is safe and effective in preventing hospital-acquired infections in patients who require prolonged mechanical ventilation in an intensive care unit (ICU).
Pneumonia is the most frequent hospital-acquired infection in the ICU; its development is likely related to the use of a breathing tube. The tube is placed in the patient's trachea (windpipe) to assist breathing during and after an operation. Currently, breathing tubes in intubated patients are cleaned with a suction catheter that draws out secretions that accumulate in the tube. This method does not clean the tube completely, however, and within a few hours after the breathing tube is placed, bacteria may begin to grow inside the tube. Over time, as the patient breathes in and out through the tube, the bacteria may break free and enter the lungs, possibly causing pneumonia. In addition, the growth of bacteria in the tube decreases the size of the airway passage, making it more difficult to keep air moving in and out of the lungs.
Previous studies have shown that breathing tubes coated with silver-sulfadiazine prevented bacterial growth in the patient's airways and that use of the Mucus Shaver prevented accumulation of secretions in the lumen of the breathing tube, keeping the tube open. This study will determine if use of the coated tube and Mucus Shaver in patients requiring prolonged mechanical ventilation is safe and if it can reduce bacterial growth, the length of intubation and mechanical ventilation, the occurrence of pneumonia and the length of time in ICU and hospital.
Patients at San Gerardo Hospital who are 18 and older, who expect to have a breathing tube in place for more than 48 hours, and who are not allergic to silver-sulfadiazine may be eligible for this study.
Participants are randomly assigned to have either a standard breathing tube and standard cleaning or a coated tube cleaned with a Mucus Shaver. At intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. The lumen of the breathing tube is then cultured every day. When the tube is removed, or on the eighth day of intubation, a sample of secretions is collected from the mouth, the lumen of the breathing tube, and the airways. After the tube is removed, it is examined for biological and microscopic analysis.
Detailed description
Pneumonia is the most frequent hospital-acquired infection in the intensive care unit, having a significant mortality, morbidity and cost. It occurs frequently in patients who are intubated and on a ventilator. In two phase I/II clinical studies, we tested endotracheal tubes (ETT), internally coated with bacteriocidal agents, and the Mucus Shaver, which removes material from the inside of the endotracheal tube. We showed 1) no adverse events, 2) that coating the inner wall of the ETT with silver-sulfadiazine significantly reduced bacterial colonization of the ETT; and 3) the Mucus Shaver cleans the lumen, leaving the entire endotracheal tube free of secretions, and maintains the lumen diameter. In this study, to evaluate the safety and effectiveness of the Mucus Shaver with the coated ETT, we propose to conduct a randomized trial in intubated patients on prolonged mechanical ventilation.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (7 listed)
- Males and females less than 18 years old;
- Patients who are expected to be intubated for less than 48 hours;
- Patients who are allergic to silver-sulfadiazine;
- Patients who require an internal diameter of an endotracheal tube less than 7.5 mm or greater than 8.0 mm;
- Patients who do not tolerate disconnection from the ventilator:
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 |
|---|---|---|
| Prolonged Mechanical Ventilation | Behavioural | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prolonged Mechanical Ventilation in people with Infection, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in Italy.
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 7 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 2 Jul 2017. 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 Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 2 Jul 2017.