The Effect of Uroshield on Sputum-specimen Bacterial Growth

NCT06729476 | Completed

• 1 other identifier: 0278-15-SZMC
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators retrospectively register the conduct of this study after its completion.

Conditions

Mechanically Ventilated Patients

Keywords

tracheostomy; mechanical ventilation; biofilm; sputum culture; multi drug resistant organisms

Outcome Measures

Primary Outcomes (2)

• Sputum-specimen bacterial growth

  Sputum specimen collection at day 0 and then every third day for 15 days.

  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.

  six months

Study Arms (2)

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.

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.

Device: Uroshield vibrator device

Interventions

Uroshield vibrator device DEVICE

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.

Active device study arm; Sham device control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated patients

You may not qualify if:

• Less than 18 years of age, pregnant women

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Officials

• Reuven Friedmann, MD

  Shaare Zedek Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2016
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2017
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share