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EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03486002
Enrollment
8
Registered
2018-04-03
Start date
2018-07-17
Completion date
2020-04-17
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Tube Clearance

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.

Interventions

DEVICECleansweep

The Cleansweep closed suction system

DEVICEHalyard

Halyard Closed Suction System

Sponsors

Teleflex
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures8 hoursMeasurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026