IntubationPhase 2NCT01912105
Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube
A Phase 2 study testing Airway medix closed suction system and standard closed suctioning systems in people with Intubation and Expected Duration of Ventilation > 48h, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
Trial summary
Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Expected Duration of Ventilation > 48h
- What is being tested?
- Airway medix closed suction system and standard closed suctioning systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Jul 2014
- 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
- Patients admitted to an ICU
- 18 years old or more
- expected to be intubated for more than 48 hours
- less than 24 hours from intubation
- fraction of inspired oxygen set at the ventilator <80%
Who cannot join
- Current or past participation in another intervention trial conflicting with the present study
- expected survival less than 24 hours
- Acute severe asthma
- Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO
- Double lumen endotracheal tube in place
- Conditions which pose the patient at high risk if inadvertent endotracheal tube displacement occurs (laryngeal edema, cervical spine trauma, upper airways diseases with difficult reintubation)
- other contraindications posed by staff physicians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial
Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan
- Conditions
- Intubation, Expected Duration of Ventilation > 48h
- Being tested
- Airway medix closed suction system, standard closed suctioning systems
- Keywords
- endotracheal tube, ct scan, cleaning device, biofilm, mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway medix closed suction systemDevice
standard closed suctioning systemsDevice
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Airway Medix Closed Suction System Receives: Device: Airway medix closed suction system |
| control | Active comparator | standard closed suctioning systems Receives: Device: standard closed suctioning systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of secretions
Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan
Measured: within 12 hours after extubation
Secondary outcomes (1)
adverse events
report of major and minor adverse events related to the use of the device
Measured: until extubation, death or tracheostomy (approximately 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Pesenti, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Antonio Pesenti, MD, Principal investigator, San Gerardo HospitalGiacomo Bellani, MD PhD, Study director, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912105
- Sponsor's protocol ID
- 180-20130326
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2013
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.
PubMed 21926595Coppadoro A, Bellani G, Bronco A, Lucchini A, Bramati S, Zambelli V, Marcolin R, Pesenti A. The use of a novel cleaning closed suction system reduces the volume of secretions within the endotracheal tube as assessed by micro-computed tomography: a randomized clinical trial. Ann Intensive Care. 2015 Dec;5(1):57. doi: 10.1186/s13613-015-0101-9. Epub 2015 Dec 30.
PubMed 26714807
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Closed Suction System to Remove Secretions From the Endotracheal Tube: a Randomized Trial
- ClinicalTrials.gov ID
- NCT01912105
- Acronym / sponsor ID
- 180-20130326
- Conditions
- Intubation, Expected Duration of Ventilation > 48h
- Keywords
- endotracheal tube, ct scan, cleaning device, biofilm, mechanical ventilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 30 Jul 2013 (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.
Cleaning the endotracheal tube with a specifically designed device results in lower amount of secretions at extubation, assessed by micro CT scan
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: Airway medix closed suction systemAirway Medix Closed Suction System |
| control | Active comparator | Device: standard closed suctioning systemsstandard closed suctioning systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to an ICU
- 18 years old or more
- expected to be intubated for more than 48 hours
- less than 24 hours from intubation
- fraction of inspired oxygen set at the ventilator <80%
Key exclusion criteria (7 listed)
- Current or past participation in another intervention trial conflicting with the present study
- expected survival less than 24 hours
- Acute severe asthma
- Use of Extracorporeal membrane oxygenation (ECMO) or candidates for ECMO
- Double lumen endotracheal tube in place
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 |
|---|---|---|
| Airway medix closed suction system | Device | treatment |
| standard closed suctioning systems | Device | control |
Primary outcome
Volume of secretions
Time frame: within 12 hours after extubation
Volume of secretions retained inside the endotracheal tube, assessed by micro ct scan
1 secondary outcome
adverse events
Time frame: until extubation, death or tracheostomy (approximately 2 weeks)
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 25 Aug 2015.
- Background: PubMed 21926595Berra L, Coppadoro A, Bittner EA, Kolobow T, Laquerriere P, Pohlmann JR, Bramati S, Moss J, Pesenti A. A clinical assessment of the Mucus Shaver: a device to keep the endotracheal tube free from secretions. Crit Care Med. 2012 Jan;40(1):119-24. doi: 10.1097/CCM.0b013e31822e9fe3.
- Derived from this study: PubMed 26714807Coppadoro A, Bellani G, Bronco A, Lucchini A, Bramati S, Zambelli V, Marcolin R, Pesenti A. The use of a novel cleaning closed suction system reduces the volume of secretions within the endotracheal tube as assessed by micro-computed tomography: a randomized clinical trial. Ann Intensive Care. 2015 Dec;5(1):57. doi: 10.1186/s13613-015-0101-9. Epub 2015 Dec 30.
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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.
Antonio Pesenti, MD principal investigator
San Gerardo Hospital
Giacomo Bellani, MD PhD study director
San Gerardo Hospital
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 Airway medix closed suction system and standard closed suctioning systems in people with Intubation and Expected Duration of Ventilation > 48h, run by Azienda Ospedaliera San Gerardo di Monza 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 5 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 25 Aug 2015. 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.
What does the primary outcome measure?
Volume of secretions (time frame: within 12 hours after extubation). 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 NCT01912105, which also lists 2 linked publications.
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 25 Aug 2015.