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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2022-05-01

Brief Summary

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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.

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Detailed Description

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suctioning will be performed in both groups as per department policy (Catheter advanced until resistance is met and withdrawn slowly for a duration no longer than 15 seconds while applying negative pressure).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

Conditions

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Mechanical Ventilation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CleanSweep Closed Suction System

Device that includes balloon sweeping technology

Group Type EXPERIMENTAL

CleanSweep Closed Suction System

Intervention Type DEVICE

Device with balloon sweeping technology

Standard in-line suction device

In-line suction device already in on intubated patients with an endotracheal tube

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CleanSweep Closed Suction System

Device with balloon sweeping technology

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No