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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03486002
Recruitment Status : Terminated (Access to the devices was halted by the sponsor)
First Posted : April 3, 2018
Last Update Posted : September 23, 2020
Information provided by (Responsible Party):
Duke University

Brief Summary:

This study is designed to compare the effectiveness of a closed suction system with an inflatable balloon on the catheter (Cleansweep system) to that of a standard closed suction system in terms of reducing the interior resistance of endotracheal tubes. Subjects who require frequent suctioning ( > every 2.5 hours) and who have stable cardiovascular systems will be randomized to receive suctioning either through the Cleansweep system or standard system initially followed by the corresponding system. The subjects will be suctioned every two hours for eight hours ( the first 2 suction procedures with one system followed by 2 with the other system). After each suction procedure measurements of resistance will be made using peak and plateau pressures.

Analysis: For each patient, data for both procedures on each catheter system will be pooled and mean differences between the standard system and the Cleansweep system will be calculated. For all 20 patients the mean (+/- SD) of these differences will be calculated and significance will be sought using appropriate statistical tests. The study will be unblinded and randomization determines merely which system will used initially for the first 2 procedures.

Condition or disease Intervention/treatment Phase
Endotracheal Tube Clearance Device: Cleansweep Device: Halyard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : April 17, 2020
Actual Study Completion Date : April 17, 2020

Arm Intervention/treatment
Cleansweep closed suction system Device: Cleansweep
The Cleansweep closed suction system

Halyard closed suction system Device: Halyard
Halyard Closed Suction System

Primary Outcome Measures :
  1. Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures [ Time Frame: 8 hours ]
    Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Intubated, mechanically ventilated patients who require suctioning more often than every 2.5 hours

Exclusion Criteria:

  • Unstable cardiovascular system (significant arrythmias, blood pressure support requiring > 2 pressors
  • refractory hypoxemia (P/F ratio < 80)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03486002

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United States, North Carolina
Duke Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Principal Investigator: Neil MacIntyre Duke University
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Responsible Party: Duke University Identifier: NCT03486002    
Other Study ID Numbers: Pro00087066
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No