Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
1 other identifier
interventional
272
1 country
1
Brief Summary
The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to first successful spontaneous breathing trial in mechanically ventilated patients in the medical intensive care unit. Secondary aims of this study are to evaluate the use endotracheal tube sweeping compared to closed suctioning effect on length of mechanical ventilation, length of ICU stay, length of total hospital stay, and occurrence of ventilator-associated events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedResults Posted
Study results publicly available
March 21, 2023
CompletedMarch 23, 2023
March 1, 2023
2.5 years
March 5, 2019
February 13, 2023
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Length of Time on a Mechanical Ventilator
Length of time on mechanical ventilation was recorded in hours.
Hospital admission to discharge (up to about 20 days)
Secondary Outcomes (4)
Time to First Successful Spontaneous Breathing Trial (SBT)
Hospital admission to discharge (up to about 20 days)
Length of Time in the Intensive Care Unit
Hospital admission to discharge (up to about 20 days)
Length of Total Hospital Stay
Hospital admission to discharge (up to about 20 days)
Number of Participants With Ventilator-associated Events
Hospital admission to discharge (up to about 20 days)
Study Arms (2)
CleanSweep Closed Suction System
EXPERIMENTALDevice that includes balloon sweeping technology
Standard in-line suction device
NO INTERVENTIONIn-line suction device already in on intubated patients with an endotracheal tube
Interventions
Device with balloon sweeping technology
Eligibility Criteria
You may qualify if:
- Orally intubated patient with endotracheal tube
- Mechanically ventilated less than 24 hours prior to enrollment
You may not qualify if:
- Less than 18 years old
- Tracheostomy tube
- Extracorporeal membrane oxygenation
- Transfer from outside hospital with more than 24 hours of mechanical ventilation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rush University Medical Center
Chicago, Illinois, 60187, United States
Results Point of Contact
- Title
- Dr. J. Brady Scott
- Organization
- Rush University
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan B Scott, MSc
Rush University University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2019
First Posted
March 11, 2019
Study Start
October 28, 2019
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
March 23, 2023
Results First Posted
March 21, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share