Ventilator Associated PneumoniaNCT02120001
Efficacy Study on Silver-coated ETT Cleaned With a Novel Device
A study testing ETT cleaning maneuver in people with Ventilator Associated Pneumonia and Critically Ill, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia, Critically Ill
- What is being tested?
- ETT cleaning maneuver
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admission to Medical, Surgical or Neuro ICU
- Subjects must be enrolled within 24 hours from intubation
- Subjects expected to be intubated for at least 48 hours or longer
- Subjects have been intubated with a silver-coated ETT
Who cannot join
- Current and past participation in another interventional trial conflicting with the present study
- Pregnant women
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.
The purpose of this study is to test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.
Read the detailed description
Several studies have suggested that biofilm formation inside the ETT plays a pivotal role in VAP development and drug-resistance induction. Silver-coated ETT have proven effective in delaying but not in preventing ETT colonization and biofilm formation, due to a barrier effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove debris and biofilm and reduce the total ETT microbial load to a certain extent. The Investigators hypothesize that the routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want to assess the reduction of ETT microbial colonization in patients intubated with a silver-coated ETT and cleaned with endOclear compared to the current standard of care of silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the tubes of each enrolled patient after it has been removed, either because the patient does not need it anymore due to his/her better clinical conditions, or because there is a need of tracheostomy or because he/she dies. Specifically they will analyze how the endOclear cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this can determine distal airway inoculation and, ultimately, VAP development.
Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization.
Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from microbial colonization will prevent septic inoculation of distal airways
Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm development will reduce drug resistance rates found in ETT and distal airways isolates
The investigators will conduct a randomized clinical trial on 40 patients intubated with silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the endOclear device.
- Conditions
- Ventilator Associated Pneumonia, Critically Ill
- Being tested
- ETT cleaning maneuver
- Keywords
- Medical Devices, Ventilator-Associated Pneumonia (VAP), Ventilator-Associated Events (VAE), Endotracheal Tube, Microbial Diversity, Drug-Resistance, biofilms, endotracheal intubation, mechanical ventilation
- Medical subject headings
- Pneumonia, Ventilator-Associated, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT cleaning maneuverDevice
Also called endOclear
EndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions.
We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period.
| Study group | Role | What they receive |
|---|---|---|
| ETT cleaning maneuver | Experimental | Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care. Receives: Device: ETT cleaning maneuver |
| Standard of care | No intervention | In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal Tube Colonization
Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).
Measured: At extubation (an expected average of 7 days)
Secondary outcomes (1)
Microbiological Colonization of Distal Airways
Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.
Measured: At extubation (An expected average of 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startJun 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Rhode Island Hospital
- Responsible party
- Principal investigator, Robert M. Kacmarek, Massachusetts General Hospital
- Investigators
- Robert Kacmarek, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120001
- Sponsor's protocol ID
- DAN1000AM
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2014
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pirrone M, Imber DA, Marrazzo F, Pinciroli R, Zhang C, Bry L, Delaney ML, Dubois AM, Thomas JG, Nistico L, Melton-Kreft R, Bittner EA, Kacmarek RM, Berra L. Silver-Coated Endotracheal Tubes Cleaned With a Mechanism for Secretion Removal. Respir Care. 2019 Jan;64(1):1-9. doi: 10.4187/respcare.06222. Epub 2018 Sep 4.
PubMed 30181363
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silver-coated Endotracheal Tube Cleaned With a Novel Mechanism for Secretion Removal: a Randomized Controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT02120001
- Acronym / sponsor ID
- DAN1000AM
- Conditions
- Ventilator Associated Pneumonia, Critically Ill
- Keywords
- Medical Devices, Ventilator-Associated Pneumonia (VAP), Ventilator-Associated Events (VAE), Endotracheal Tube, Microbial Diversity, Drug-Resistance, biofilms, endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Rhode Island Hospital
- Study start
- Jun 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Posted 19 May 2017
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 test the efficacy of a novel cleaning device in keeping silver-coated endotracheal tubes free from bacterial colonization.
Detailed description
Several studies have suggested that biofilm formation inside the ETT plays a pivotal role in VAP development and drug-resistance induction. Silver-coated ETT have proven effective in delaying but not in preventing ETT colonization and biofilm formation, due to a barrier effect of biofilm and accumulated debris. Advanced ETT cleaning devices are able to remove debris and biofilm and reduce the total ETT microbial load to a certain extent. The Investigators hypothesize that the routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization. The Investigators therefore want to assess the reduction of ETT microbial colonization in patients intubated with a silver-coated ETT and cleaned with endOclear compared to the current standard of care of silver-coated ETT (blind suctioning). They plan to achieve this result by analyzing the tubes of each enrolled patient after it has been removed, either because the patient does not need it anymore due to his/her better clinical conditions, or because there is a need of tracheostomy or because he/she dies. Specifically they will analyze how the endOclear cleaning maneuver affects microbial colonization in the inner layer of the ETT and how this can determine distal airway inoculation and, ultimately, VAP development.
Specific AIM #1: Investigators will test the hypothesis that routine use of endOclear in patients intubated with a silver-coated ETT will reduce ETT microbial colonization.
Specific AIM #2: Investigators will test the hypothesis that keeping ETTs free from microbial colonization will prevent septic inoculation of distal airways
Specific AIM #3: Investigators will test the hypothesis that prevention of ETT biofilm development will reduce drug resistance rates found in ETT and distal airways isolates
The investigators will conduct a randomized clinical trial on 40 patients intubated with silver-coated ETT and randomized to receive standard ETT cleaning vs cleaning with the endOclear device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETT cleaning maneuver | Experimental | Device: ETT cleaning maneuverPatients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care. |
| Standard of care | No intervention | –In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to Medical, Surgical or Neuro ICU
- Subjects must be enrolled within 24 hours from intubation
- Subjects expected to be intubated for at least 48 hours or longer
- Subjects have been intubated with a silver-coated ETT
Key exclusion criteria (3 listed)
- Current and past participation in another interventional trial conflicting with the present study
- Pregnant women
- Prisoner status
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 |
|---|---|---|
| ETT cleaning maneuverAlso: endOclearEndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions. We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period. | Device | ETT cleaning maneuver |
Primary outcome
Endotracheal Tube Colonization
Time frame: At extubation (an expected average of 7 days)
Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).
1 secondary outcome
Microbiological Colonization of Distal Airways
Time frame: At extubation (An expected average of 7 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30181363Pirrone M, Imber DA, Marrazzo F, Pinciroli R, Zhang C, Bry L, Delaney ML, Dubois AM, Thomas JG, Nistico L, Melton-Kreft R, Bittner EA, Kacmarek RM, Berra L. Silver-Coated Endotracheal Tubes Cleaned With a Mechanism for Secretion Removal. Respir Care. 2019 Jan;64(1):1-9. doi: 10.4187/respcare.06222. Epub 2018 Sep 4.
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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.
Robert Kacmarek, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT cleaning maneuver in people with Ventilator Associated Pneumonia and Critically Ill, run by Massachusetts General Hospital at 1 site in United States.
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 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 19 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endotracheal Tube Colonization (time frame: At extubation (an expected average of 7 days)). 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 NCT02120001, 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 19 May 2017; AzTrials last refreshed its copy on 27 Oct 2026.