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EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

Duke University logo

Duke University

Status

Terminated

Conditions

Endotracheal Tube Clearance

Treatments

Device: Cleansweep
Device: Halyard

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03486002
Pro00087066

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

8 participants in 2 patient groups

Cleansweep closed suction system
Other group
Treatment:
Device: Cleansweep
Halyard closed suction system
Other group
Treatment:
Device: Halyard

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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