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TerminatedNCT03486002Updated Sep 23, 2020

EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

An interventional study of Cleansweep and Halyard in Endotracheal Tube Clearance, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

Why this study was terminated
Access to the devices was halted by the sponsor
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Endotracheal Tube Clearance
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unstable cardiovascular system (significant arrythmias, blood pressure support requiring > 2 pressors
  • refractory hypoxemia (P/F ratio \< 80)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    Cleansweep closed suction system

    Device: Cleansweep

  • Other
    Halyard closed suction system

    Device: Halyard

Interventions

  • DeviceCleansweep

    The Cleansweep closed suction system

  • DeviceHalyard

    Halyard Closed Suction System

05

What researchers measure

Primary outcomes

  1. Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures

    Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)

    Time frame: 8 hours

06

Study locations

1 site
  • Duke Health System
    Durham, North Carolina 27710, United States
07

Registry details

Key details

Study ID
NCT03486002
Lead sponsor
Duke University
Collaborators
Teleflex
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Jul 17, 2018
Primary completion
Apr 17, 2020
Completion
Apr 17, 2020
Last update
Sep 23, 2020

Study contacts

Neil MacIntyre
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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