Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
Phase: NA
Conditions: Mechanical Ventilation Complication
Sponsor: Rush University Medical Center

5.15.2020 
 
 
Study Title: Evaluation of the CleanSweep™ Closed Suction System on Length of 
Mechanical Ventilation and Ventilator-Associated Events  
Principal Investigator: 
J. Brady Scott, MSc, RRT, RRT-ACCS, AE-C, FAARC, FCCP 
Associate Professor, Director of Clinical Education 
Rush University, Department of Respiratory Care 
Co-Investigator(s): 
David L. Vines, PhD, MHS, RRT, FAARC, FCCP 
Associate Professor, Chair and Respiratory Care Program Director 
 
Rush University, Department of Cardiopulmonary Sciences 
 
Robert Balk, MD 
Professor of Medicine, Director of Pulmonary, Critical Care, and Sleep Medicine 
Rush University Medical Center 
 
Ramandeep Kaur, MSc, RRT, RRT-ACCS 
Respiratory Therapist III 
Rush University Medical Center  
 
Kathryn Dugan, BSRT, RRT-NPS 
Respiratory Care Practitioner III  
Rush University Medical Center 

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Andrew Klein, MS, RRT-ACCS, RRT-NPS, AE-C 
Respiratory Care Practitioner III 
Rush University Medical Center 
 
Tyler Weiss, MSc, RRT, RRT-ACCS, AE-C 
Respiratory Care Practitioner III 
Rush University Medical Center 
 
Ashley Lachowicz, MSc, RRT-ACCS, NPS, AE-C 
Respiratory Care Practitioner III 
Rush University Medical Center 
 
Student (s): 
Kimberly Anne Villanueva 
Respiratory Care Student, Rush University 
 
Megan Charlton  
Respiratory Care Student, Rush University 
 
 
 

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Specific Aims  
The primary aim of this study is to evaluate the CleanSweep™ Closed Suction System on time to 
first successful SBT 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. 
Introduction 
 Mechanical ventilation (MV) is utilized when the patient’s work of breathing (WOB) 
exceeds their capacity to do that work, with risk of respiratory muscle failure. Approximately 
half of the time spent on MV is on the process of weaning and discontinuing this support as soon 
as possible. The focus on MV liberation is due to the associated complications, including an 
increased risked of pneumonia.1 The weaning process can be challenging and is categorized as 
simple, difficult, or prolonged in regards to weaning success.1 Difficult to wean patients are 
categorized as such by failing their initial spontaneous breathing trial (SBT) and require up to 
three subsequent SBTs to pass; or up to seven days to completely wean from mechanical 
ventilation after the initial SBT. The difficult and prolonged to wean groups account for 
approximately 31% of the patients weaned from mechanical ventilation. It has been reported that 
these groups combined account for a 25% mortality rate.1 Others reported the incidence and 
mortality related to these weaning categories in a large cohort study on 257 patients, where the 
simple to wean group represented 59% with a mortality rate of 13%, the difficult to wean group 
represented 26% of patients with a 9% mortality rate, and the prolonged weaning group 
represented 14% of the group with a 32% mortality rate.2 
Evidence-based guidelines were published over a decade ago to help guide the weaning 
process and are still applicable today. Once the acute underlying disease process associated with 
the initiation of mechanical ventilation has improved and spontaneous breathing efforts are 
evident, patients are assessed for their readiness to wean and extubate. Physiologic signs 
including respiratory pattern, gas exchange, hemodynamic stability, body temperature, 
hemoglobin levels, and mental status are all used to determine the discontinuation of mechanical 
ventilator support.3 Patients are then assessed for discontinuation of mechanical ventilation by 

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using a SBT. A SBT involves a low level of mechanical ventilatory support or a T-piece attached 
to the endotracheal tube. The methods of performing a SBT are variable and the 
recommendations from the literature are inconsistent on this topic. The main purpose of the SBT 
is to mimic spontaneous breathing to assess a patient’s ability to breathe without the assistance of 
a mechanical ventilator.3,4  
A SBT is performed to evaluate a patient’s ability to balance the respiratory load with 
their respiratory capacity. Factors that cause a load/capacity imbalance (e.g., increased RAW, 
decreased lung compliance) often result in failed SBTs. Because of this, clinicians should ensure 
proper conditions when performing SBTs. Mucus buildup in the endotracheal tube, which results 
in luminal narrowing of the tube, can cause this load/capacity imbalance due to the increase in 
RAW.5 Mietto et al noted that ETT luminal narrowing is common and can increase in airflow 
resistance. They noted that this narrowing occurred despite adequate humidification and 
suctioning.6 Wilson and colleagues studied the pressure drop across a sample of used ETTs and 
found that 33% of these tubes reflected an inner diameter change that matched an unused tube 
one size smaller. They also reported that in approximately 20-35% of patients, the change in 
pressure was greater than 5 cm H2O.7 Others have reported that endotracheal tube obstruction 
occurs more often than previously suspected and the onset can be as soon as 24 hours.8 
We previously studied the impact of ETT scraping on RAW and found a statistically 
significant reduction.9 There is currently little to no data related to the frequency and impact of 
ETT scraping or sweeping on patient outcomes. However, we now use devices in our facility that 
have the ability to sweep ETTs; in addition to inline suction catheters (termed standard in this 
document) that cannot sweep ETTs. Thus, the primary aim of this study is to evaluate the 
CleanSweep™ Closed Suction System, which is used at Rush University Medical Center, on 
time to first successful SBT 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. 
Experimental Design and methods  
 This is designed as a prospective, randomized control trial, in a large, urban, academic 

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medical center. This study will include mechanically ventilated patients (n = 272) in the medical 
intensive care unit (MICU) and adult intensive care unit 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 comparison group will be placed on the CleanSweep™ Closed Suction 
System immediately after intubation or upon arrival to the MICU. ETTs will be cleaned with the 
balloon sweeping technology every time a respiratory therapist suctions the patient. The standard 
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, DVT prevention, daily sedation interruption and SBT, and oral care every 
4 hours with chlorhexidine at 12pm (noon) and 12am midnight. 
Procedures Done for Research Purpose  
• Comparison Group (CleanSweep™ Closed Suction System) 
o In addition to suctioning performed as per department policy, ETTs cleaned with 
balloon sweeping technology with every respiratory therapist suctioning. 
• Standard Group (Standard in-line suction device) 
o Suctioning performed as per department policy  
Subject Population 
Two hundred and seventy-two orally intubated, adult patients ≥ 18 year of age will be enrolled.     
Inclusion criteria: 
• 
Age ≥ 18 y/o  
• 
Orally intubated with endotracheal tube 
• 
Mechanically ventilated < 24 hours prior to enrollment 
Exclusion criteria:  

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• Age < 18 y/o 
• Tracheostomy tube 
• Extracorporeal membrane oxygenation 
• Transfer from outside hospital with more than 24 hours of mechanical ventilation 
Recruitment and Consent Procedures: 
• Recruitment will be based on the inclusion and exclusion criteria.  
Compensation: 
• There will be no compensation provided to participants for participation in this study. 
Risk to subject: 
• Risks include potential desaturation during ETT scraping. To prevent or lessen the 
possibility of oxygen desaturation, the patient will be preoxygenated with 100% oxygen 
for 1 to 2 minutes before ETT cleaning is performed.  
Special Precautions: 
• All study material will be coded to de-identify participants and a separate list will be kept 
with the participant’s ID and name. 
• All identifiers will be removed prior to analysis. Study subjects will not be re-identified 
or contacted after data collection is complete.  
Confidentiality: 
• The study investigators, along with the IRB, will have access to the individual 
participant’s results. Neither names nor personal information will be recorded or included 
in the data analysis. The investigators will strictly adhere to IRB guidelines to ensure that 
participant’s confidentiality is maintained. 
Plans for Data Analysis: 
• Calculated sample size. Based on previous institutional data, length of mechanical 

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ventilation is approximately 6.3 days with a standard deviation of 3.64. Effect is 
estimated at a 20% reduction in the length of mechanical ventilation (6.3 x .20 = 1.26 
days). Standardized effect size would be 35% (1.26/3.64). Setting alpha at 0.05 and 
power of .80 with standardized effect size of 0.35 would require 136 patients in each 
group or 272 total number of subjects. Estimated completion would be 18 to 24 months.   
• Data for each patient will be recorded in REDCap, a secure web-based database. 
Descriptive and inferential statistics were calculated from the information collected from 
patients’ charts. Patients were divided into two groups based on randomization. Each 
group’s time to first successful SBT and length of mechanical ventilation outcomes will 
be compared using an independent T-test if the data is normally distributed. Ventilator-
associated conditions and infection related ventilation associated complications rates for 
both groups will be compared using Chi-Square analysis. Level of significance will be set 
at p < 0.05.   
  
References: 
1. Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, et al. Weaning from 
mechanical ventilation. Eur Respir J 2007;29(5):1033-1056.  
2. Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, et al. Incidence 
and outcome of weaning from mechanical ventilation according to new categories. Eur 
Respir J 2010;35(1):88-94.  
3. MacIntyre NR, Cook DJ, Ely EW,Jr, Epstein SK, Fink JB, Heffner JE, et al. Evidence-
based guidelines for weaning and discontinuing ventilatory support: a collective task 
force facilitated by the American College of Chest Physicians; the American Association 
for Respiratory Care; and the American College of Critical Care Medicine. Chest 
2001;120(6 Suppl):375S-95S.  
4. Pellegrini JA, Moraes RB, Maccari JG, de Oliveira RP, Savi A, Ribeiro RA, et al. 
Spontaneous Breathing Trials With T-Piece or Pressure Support Ventilation. Respir Care 
2016. 
5. Shah C, Kollef MH. Endotracheal tube intraluminal volume loss among mechanically 
ventilated patients. Crit Care Med 2004;32(1):120-125.  
6. Mietto C, Pinciroli R, Piriyapatsom A, Thomas JG, Bry L, Delaney ML, et al. Tracheal 
tube obstruction in mechanically ventilated patients assessed by high-resolution 
computed tomography. Anesthesiology 2014;121(6):1226-1235.  
7. Wilson A, Gray D, Thomas J. Increases in endotracheal tube resistance are unpredictable 
relative to duration of intubation. Chest 2009;136(4):1006-1013.  

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8. Berra L, Coppadoro A, Bittner E, Kolobow T, Laquerriere P, Pohlmann J, et al. A clinical 
assessment of the Mucus Shaver: a device to keep the endotracheal tube free from 
secretions. Crit Care Med 2012;40(1):119-124 
9. Scott JB, Dubosky MN, Vines DL, Sulaiman AS, Jendral KR, Singh G, Patel A, Kaplan CA, 
Gurka DP, Balk RA. Evaluation of Endotracheal Tube Scraping on Airway Resistance. 
Respiratory Care. 2017;62 (11):1423-1427.