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

Mechanical Ventilation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868735
• Other study ID #: 18110802
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: March 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• CleanSweep Closed Suction System
Device with balloon sweeping technology

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Length of Total Hospital Stay	Length of total time spent in the hospital in 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	Hospital admission to discharge (up to about 20 days)