Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT03868735
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2019-03-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Sponsor:
Rush University Medical Center
Organization:
Study Overview
Official Title:
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: