Clinical trial NCT03868735: Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Official title: Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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

Eligibility criteria: 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

Primary outcomes:
measure: Length of Time on a Mechanical Ventilator
timeFrame: Hospital admission to discharge (up to about 20 days)
Secondary outcomes:
measure: Time to First Successful Spontaneous Breathing Trial (SBT)
timeFrame: Hospital admission to discharge (up to about 20 days)
measure: Length of Time in the Intensive Care Unit
timeFrame: Hospital admission to discharge (up to about 20 days)
measure: Length of Total Hospital Stay
timeFrame: Hospital admission to discharge (up to about 20 days)
measure: Number of Participants With Ventilator-associated Events
timeFrame: Hospital admission to discharge (up to about 20 days)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University University Medical Center
name: Jonathan B Scott, MSc
role: PRINCIPAL_INVESTIGATOR
References: