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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.
This is designed as a prospective, randomized control trial, in a large, urban, academic medical center. This study will include mechanically ventilated patients (n = 272) in the medical intensive care unit (MICU) at Rush University Medical Center. It will exclude patients with a tracheostomy on admission, those requiring extracorporeal membrane oxygenation (ECMO), or transferred from an outside facility receiving more than 24 hours of mechanical ventilation. Two groups will be randomly assigned via computer randomization. The experimental group will be placed on the CleanSweep™ Closed Suction System immediately after intubation or upon arrival to the MICU. Endotracheal tubes (ETTs) will be cleaned with the balloon sweeping technology every time a respiratory therapist suctions the patient. The control group will be placed on the standard in-line suction device. Airway suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure). Both groups will also receive a ventilator bundle that consists of head of bed elevation, ETT cuff pressure management, deep vein thrombosis prevention, daily sedation interruption and SBT, and oral care every 4 hours with chlorhexidine at 12pm (noon) and 12am midnight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CleanSweep Closed Suction System | Experimental | Device that includes balloon sweeping technology |
|
| Standard in-line suction device | No Intervention | In-line suction device already in on intubated patients with an endotracheal tube |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CleanSweep Closed Suction System | Device | Device with balloon sweeping technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Successful Spontaneous Breathing Trial (SBT) | Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit. | Hospital admission to discharge (up to about 20 days) |
| Length of Time in the Intensive Care Unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan B Scott, MSc | Rush University University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60187 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CleanSweep Closed Suction System | Device that includes balloon sweeping technology CleanSweep Closed Suction System: Device with balloon sweeping technology |
| FG001 | Standard In-line Suction Device | In-line suction device already in on intubated patients with an endotracheal tube |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CleanSweep Closed Suction System | Device that includes balloon sweeping technology CleanSweep Closed Suction System: Device with balloon sweeping technology |
| BG001 | Standard In-line Suction Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Time on a Mechanical Ventilator | Length of time on mechanical ventilation was recorded in hours. | Posted | Median | Inter-Quartile Range | hours | Hospital admission to discharge (up to about 20 days) |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CleanSweep Closed Suction System | Device that includes balloon sweeping technology CleanSweep Closed Suction System: Device with balloon sweeping technology |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Brady Scott | Rush University | 3129426389 | jonathan_b_scott@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2020 | Mar 14, 2023 | Prot_SAP_001.pdf |
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Length of time spent in the intensive care units in days |
| Hospital admission to discharge (up to about 20 days) |
| Length of Total Hospital Stay | Length of total time spent in the hospital in days | Hospital admission to discharge (up to about 20 days) |
| Number of Participants With Ventilator-associated Events | Number of Participants with ventilator-associated events, like pneumonia | Hospital admission to discharge (up to about 20 days) |
In-line suction device already in on intubated patients with an endotracheal tube
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Time to First Successful Spontaneous Breathing Trial (SBT) | Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit. | Posted | Median | Inter-Quartile Range | hours | Hospital admission to discharge (up to about 20 days) |
|
|
|
| Secondary | Length of Time in the Intensive Care Unit | Length of time spent in the intensive care units in days | Posted | Median | Inter-Quartile Range | days | Hospital admission to discharge (up to about 20 days) |
|
|
|
| Secondary | Length of Total Hospital Stay | Length of total time spent in the hospital in days | Posted | Median | Inter-Quartile Range | days | Hospital admission to discharge (up to about 20 days) |
|
|
|
| Secondary | Number of Participants With Ventilator-associated Events | Number of Participants with ventilator-associated events, like pneumonia | Posted | Number | participants | Hospital admission to discharge (up to about 20 days) |
|
|
|
| 0 |
| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | Standard In-line Suction Device | In-line suction device already in on intubated patients with an endotracheal tube | 0 | 136 | 0 | 136 | 0 | 136 |
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