Trial Outcomes & Findings for Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events (NCT NCT03868735)
NCT ID: NCT03868735
Last Updated: 2023-03-23
Results Overview
Length of time on mechanical ventilation was recorded in hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
272 participants
Primary outcome timeframe
Hospital admission to discharge (up to about 20 days)
Results posted on
2023-03-23
Participant Flow
Participant milestones
| Measure |
CleanSweep Closed Suction System
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Overall Study
STARTED
|
136
|
136
|
|
Overall Study
COMPLETED
|
136
|
136
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Baseline characteristics by cohort
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
Total
n=272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Years
n=5 Participants
|
63 Years
n=7 Participants
|
63 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
57 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
31 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
136 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Body Mass Index
|
28.8 kg/m^2
n=5 Participants
|
29.3 kg/m^2
n=7 Participants
|
29.05 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Hospital admission to discharge (up to about 20 days)Length of time on mechanical ventilation was recorded in hours.
Outcome measures
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Length of Time on a Mechanical Ventilator
|
70.6 hours
Interval 37.0 to 148.0
|
72.2 hours
Interval 37.0 to 187.0
|
SECONDARY outcome
Timeframe: Hospital admission to discharge (up to about 20 days)Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.
Outcome measures
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Time to First Successful Spontaneous Breathing Trial (SBT)
|
45.7 hours
Interval 27.0 to 95.0
|
46.7 hours
Interval 30.0 to 87.0
|
SECONDARY outcome
Timeframe: Hospital admission to discharge (up to about 20 days)Length of time spent in the intensive care units in days
Outcome measures
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Length of Time in the Intensive Care Unit
|
7.8 days
Interval 4.0 to 18.0
|
9 days
Interval 4.0 to 20.0
|
SECONDARY outcome
Timeframe: Hospital admission to discharge (up to about 20 days)Length of total time spent in the hospital in days
Outcome measures
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Length of Total Hospital Stay
|
13.9 days
Interval 8.0 to 25.0
|
14.7 days
Interval 8.0 to 26.0
|
SECONDARY outcome
Timeframe: Hospital admission to discharge (up to about 20 days)Number of Participants with ventilator-associated events, like pneumonia
Outcome measures
| Measure |
CleanSweep Closed Suction System
n=136 Participants
Device that includes balloon sweeping technology
CleanSweep Closed Suction System: Device with balloon sweeping technology
|
Standard In-line Suction Device
n=136 Participants
In-line suction device already in on intubated patients with an endotracheal tube
|
|---|---|---|
|
Number of Participants With Ventilator-associated Events
|
16 participants
|
9 participants
|
Adverse Events
CleanSweep Closed Suction System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard In-line Suction Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place