Mechanical Ventilation ComplicationNCT03868735
Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
A study testing CleanSweep Closed Suction System in people with Mechanical Ventilation Complication, run by Rush University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- CleanSweep Closed Suction System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 1 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orally intubated patient with endotracheal tube
- Mechanically ventilated less than 24 hours prior to enrollment
Who cannot join
- Less than 18 years old
- Tracheostomy tube
- Extracorporeal membrane oxygenation
- Transfer from outside hospital with more than 24 hours of mechanical ventilation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60187
About this study
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.
Read the 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.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- CleanSweep Closed Suction System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CleanSweep Closed Suction SystemDevice
Device with balloon sweeping technology
| Study group | Role | What they receive |
|---|---|---|
| CleanSweep Closed Suction System | Experimental | Device that includes balloon sweeping technology Receives: Device: CleanSweep Closed Suction System |
| Standard in-line suction device | No intervention | In-line suction device already in on intubated patients with an endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Time on a Mechanical Ventilator
Length of time on mechanical ventilation was recorded in hours.
Measured: Hospital admission to discharge (up to about 20 days)
Secondary outcomes (4)
Time to First Successful Spontaneous Breathing Trial (SBT)
Time to first successful SBT in mechanically ventilated patients in the medical intensive care unit.
Measured: Hospital admission to discharge (up to about 20 days)
Length of Time in the Intensive Care Unit
Length of time spent in the intensive care units in days
Measured: Hospital admission to discharge (up to about 20 days)
Length of Total Hospital Stay
Length of total time spent in the hospital in days
Measured: Hospital admission to discharge (up to about 20 days)
Number of Participants With Ventilator-associated Events
Number of Participants with ventilator-associated events, like pneumonia
Measured: Hospital admission to discharge (up to about 20 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start28 Oct 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan B Scott, MSc, Principal investigator, Rush University University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868735
- Sponsor's protocol ID
- 18110802
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2019
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CleanSweep™ Closed Suction System on Length of Mechanical Ventilation and Ventilator-Associated Events
- ClinicalTrials.gov ID
- NCT03868735
- Acronym / sponsor ID
- 18110802
- Conditions
- Mechanical Ventilation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CleanSweep Closed Suction System | Experimental | Device: CleanSweep Closed Suction SystemDevice that includes balloon sweeping technology |
| Standard in-line suction device | No intervention | –In-line suction device already in on intubated patients with an endotracheal tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Orally intubated patient with endotracheal tube
- Mechanically ventilated less than 24 hours prior to enrollment
Key exclusion criteria (4 listed)
- Less than 18 years old
- Tracheostomy tube
- Extracorporeal membrane oxygenation
- Transfer from outside hospital with more than 24 hours of mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CleanSweep Closed Suction SystemDevice with balloon sweeping technology | Device | CleanSweep Closed Suction System |
Primary outcome
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.
4 secondary outcomes
Time to First Successful Spontaneous Breathing Trial (SBT)
Time frame: Hospital admission to discharge (up to about 20 days)
Length of Time in the Intensive Care Unit
Time frame: Hospital admission to discharge (up to about 20 days)
Length of Total Hospital Stay
Time frame: Hospital admission to discharge (up to about 20 days)
Number of Participants With Ventilator-associated Events
Time frame: Hospital admission to discharge (up to about 20 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan B Scott, MSc principal investigator
Rush University University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CleanSweep Closed Suction System in people with Mechanical Ventilation Complication, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Time on a Mechanical Ventilator (time frame: Hospital admission to discharge (up to about 20 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.