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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03868735

Enrollment

272

Registered

2019-03-11

Start date

2019-10-28

Completion date

2022-05-01

Last updated

2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication

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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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

Interventions

DEVICECleanSweep Closed Suction System

Device with balloon sweeping technology

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Length of Time on a Mechanical Ventilator	Hospital admission to discharge (up to about 20 days)	Length of time on mechanical ventilation was recorded in hours.

Secondary

Measure	Time frame	Description
Time to First Successful Spontaneous Breathing Trial (SBT)	Hospital admission to discharge (up to about 20 days)	Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.
Length of Time in the Intensive Care Unit	Hospital admission to discharge (up to about 20 days)	Length of time spent in the intensive care units in days
Length of Total Hospital Stay	Hospital admission to discharge (up to about 20 days)	Length of total time spent in the hospital in days
Number of Participants With Ventilator-associated Events	Hospital admission to discharge (up to about 20 days)	Number of Participants with ventilator-associated events, like pneumonia

Countries

United States

Participant flow

Participants by arm

Arm	Count
CleanSweep Closed Suction System Device that includes balloon sweeping technology CleanSweep Closed Suction System: Device with balloon sweeping technology	136
Standard In-line Suction Device In-line suction device already in on intubated patients with an endotracheal tube	136
Total	272

Baseline characteristics

Characteristic	Total	CleanSweep Closed Suction System	Standard In-line Suction Device
Age, Continuous	63 Years	63 Years	63 Years
Body Mass Index	29.05 kg/m^2	28.8 kg/m^2	29.3 kg/m^2
Race/Ethnicity, Customized African American	108 Participants	57 Participants	51 Participants
Race/Ethnicity, Customized Asian	9 Participants	4 Participants	5 Participants
Race/Ethnicity, Customized Caucasian	66 Participants	36 Participants	30 Participants
Race/Ethnicity, Customized Hispanic	75 Participants	31 Participants	44 Participants
Race/Ethnicity, Customized Other	14 Participants	8 Participants	6 Participants
Region of Enrollment United States	272 Participants	136 Participants	136 Participants
Sex: Female, Male Female	129 Participants	58 Participants	71 Participants
Sex: Female, Male Male	143 Participants	78 Participants	65 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 136	0 / 136
other Total, other adverse events	0 / 136	0 / 136
serious Total, serious adverse events	0 / 136	0 / 136