Skip to main content
OpenTrials
Completed

NCT Number: NCT03868735

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60187, United States

About this study

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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CleanSweep Closed Suction System

Device

Device with balloon sweeping technology

Primary outcomes

  1. Length of Time on a Mechanical Ventilator

    Time frame: Hospital admission to discharge (up to about 20 days)

    Length of time on mechanical ventilation was recorded in hours.

Secondary outcomes

  1. Time to First Successful Spontaneous Breathing Trial (SBT)

    Time frame: Hospital admission to discharge (up to about 20 days)

    Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.

  2. Length of Time in the Intensive Care Unit

    Time frame: Hospital admission to discharge (up to about 20 days)

    Length of time spent in the intensive care units in days

  3. Length of Total Hospital Stay

    Time frame: Hospital admission to discharge (up to about 20 days)

    Length of total time spent in the hospital in days

  4. Number of Participants With Ventilator-associated Events

    Time frame: Hospital admission to discharge (up to about 20 days)

    Number of Participants with ventilator-associated events, like pneumonia

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 11, 2019
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.