Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events

Study Overview
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Brief Summary
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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.

Detailed Description
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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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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.

Official Title
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Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events

Conditions
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Mechanical Ventilation Complication

Intervention / Treatment
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* Device: CleanSweep Closed Suction System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Orally intubated patient with endotracheal tube Mechanically ventilated less than 24 hours prior to enrollment Exclusion Criteria: Less than 18 years old Tracheostomy tube Extracorporeal membrane oxygenation Transfer from outside hospital with more than 24 hours of mechanical ventilation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CleanSweep Closed Suction System<br>Device that includes balloon sweeping technology | Device: CleanSweep Closed Suction System<br>* Device with balloon sweeping technology<br>|
| No Intervention: Standard in-line suction device<br>In-line suction device already in on intubated patients with an endotracheal tube | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |