Respiration, ArtificialNCT00932776
Tracheobronchial Secretion Removal
A study testing TBA care device in people with Respiration, Artificial and Respiratory Insufficiency, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Respiration, Artificial, Respiratory Insufficiency
- What is being tested?
- TBA care device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Men only
- Adult, Older adult
Who may be able to join
- age greater than 18 years
- presence of an endotracheal tube to provide mechanical ventilation
- expected duration of mechanical ventilation greater than 48 hours.
Who cannot join
- age < 18 years, pregnancy
- presence of active bronchial bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.
- Conditions
- Respiration, Artificial, Respiratory Insufficiency
- Being tested
- TBA care device, Control
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBA care deviceDevice
Tracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first.
ControlDevice
In this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| TBA | Experimental | Not described Receives: Device: TBA care device |
| Control | Active comparator | Not described Receives: Device: Control |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
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 Respiration, ArtificialStudies 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 N/A
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932776
- Sponsor's protocol ID
- AR HSG 268
- Status last verified
- Jul 2009
- First submitted
- 2 Jul 2009
- Last updated
- 3 Jul 2009
- Results posted
- No
Publications
Lucchini A, Zanella A, Bellani G, Gariboldi R, Foti G, Pesenti A, Fumagalli R. Tracheal secretion management in the mechanically ventilated patient: comparison of standard assessment and an acoustic secretion detector. Respir Care. 2011 May;56(5):596-603. doi: 10.4187/respcare.00909. Epub 2011 Jan 27.
PubMed 21276316
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheobronchial Secretion Removal
- ClinicalTrials.gov ID
- NCT00932776
- Acronym / sponsor ID
- AR HSG 268
- Conditions
- Respiration, Artificial, Respiratory Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- First posted
- 3 Jul 2009 (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 undergoing intubation and mechanical ventilation require removal of secretion by means of trachoebronchial suctioning. Timing of the procedure is mainly based on clinical parameters. TBA Care® is a new commercially available device designed to generate a signal when secretions are present in the respiratory tract of intubated patients, thus indicating the need for endotracheal suctioning only when necessary and prior to clinical deterioration. In a prospective randomized trial in intubated and mechanically ventilated patients of a general ICU the researchers investigated the efficacy of TBA Care® in detecting the presence of retained secretions compared to the standard indicators.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBA | Experimental | Device: TBA care device |
| Control | Active comparator | Device: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 18 years
- presence of an endotracheal tube to provide mechanical ventilation
- expected duration of mechanical ventilation greater than 48 hours.
Key exclusion criteria (2 listed)
- age < 18 years, pregnancy
- presence of active bronchial bleeding
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 |
|---|---|---|
| TBA care deviceTracheal suction maneuvers are performed according to the indications provided by the TBA care device or to clinical parameters whichever occurs first. | Device | TBA |
| ControlIn this group suction maneuvers are performed according to clinical indications or on a fixed schedule whichever comes first. | Device | Control |
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 3 Jul 2009.
- Derived from this study: PubMed 21276316Lucchini A, Zanella A, Bellani G, Gariboldi R, Foti G, Pesenti A, Fumagalli R. Tracheal secretion management in the mechanically ventilated patient: comparison of standard assessment and an acoustic secretion detector. Respir Care. 2011 May;56(5):596-603. doi: 10.4187/respcare.00909. Epub 2011 Jan 27.
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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 study testing TBA care device in people with Respiration, Artificial and Respiratory Insufficiency, run by University of Milano Bicocca 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 2 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 3 Jul 2009. 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.
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?
On the ClinicalTrials.gov record for NCT00932776, 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 3 Jul 2009.