Mechanically Ventilated PatientsNCT06729476
The Effect of Uroshield on Sputum-specimen Bacterial Growth
A study testing Uroshield vibrator device in people with Mechanically Ventilated Patients, run by Shaare Zedek Medical Center.
Trial summary
The investigators retrospectively register the conduct of this study after its completion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- Uroshield vibrator device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Aug 2017
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated patients
Who cannot join
- Less than 18 years of age, pregnant women
About this study
Official title: The Effect of Uroshield on Sputum-specimen Bacterial Growth and Multidrug Resistant Organisms in Mechanically Ventilated Patients
The investigators retrospectively register the conduct of this study after its completion.
Read the detailed description
Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.
Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients.
Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.
- Conditions
- Mechanically Ventilated Patients
- Being tested
- Uroshield vibrator device
- Keywords
- tracheostomy, mechanical ventilation, biofilm, sputum culture, multi drug resistant organisms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uroshield vibrator deviceDevice
UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.
| Study group | Role | What they receive |
|---|---|---|
| Active device study arm | Active comparator | Study Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. Receives: Device: Uroshield vibrator device |
| Sham device control arm | Placebo comparator | Study Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. Receives: Device: Uroshield vibrator device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum-specimen bacterial growth
Sputum specimen collection at day 0 and then every third day for 15 days.
Measured: six months
Growth of multidrug resistant organisms from sputum cultures
Isolation of sputum specimens collected at day 0 and then every third day for 15 days.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reuven Friedmann, MD, Study director, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729476
- Sponsor's protocol ID
- 0278-15-SZMC
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Uroshield on Sputum-specimen Bacterial Growth and Multidrug Resistant Organisms in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06729476
- Acronym / sponsor ID
- 0278-15-SZMC
- Conditions
- Mechanically Ventilated Patients
- Keywords
- tracheostomy, mechanical ventilation, biofilm, sputum culture, multi drug resistant organisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 11 Dec 2024 (actual)
- 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 investigators retrospectively register the conduct of this study after its completion.
Detailed description
Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.
Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients.
Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active device study arm | Active comparator | Device: Uroshield vibrator deviceStudy Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. |
| Sham device control arm | Placebo comparator | Device: Uroshield vibrator deviceStudy Procedure: In this study, half of the recruited patients were connected to the UROSHIELD device (study group), while the other half was connected to a similar but inactive sham device (control group). The medical treating team, research team, and the patients themselves were unaware of who received the active device and who was connected to the inactive, sham device. As mentioned, randomization and allocation of devices was performed by a physician not otherwise involved in the conduct of the study or with data processing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated patients
Key exclusion criteria (1 listed)
- Less than 18 years of age, pregnant women
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 |
|---|---|---|
| Uroshield vibrator deviceUROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals. | Device | Active device study arm, Sham device control arm |
Primary outcome
Sputum-specimen bacterial growth
Time frame: six months
Sputum specimen collection at day 0 and then every third day for 15 days.
Growth of multidrug resistant organisms from sputum cultures
Time frame: six months
Isolation of sputum specimens collected at day 0 and then every third day for 15 days.
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Reuven Friedmann, MD study director
Shaare Zedek Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Uroshield vibrator device in people with Mechanically Ventilated Patients, run by Shaare Zedek Medical Center.
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 1 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Sputum-specimen bacterial growth (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 11 Dec 2024.