EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER
NCT03486002 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2020-09-23
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.
Conditions
- Endotracheal Tube Clearance
Interventions
- DEVICE
-
Cleansweep
The Cleansweep closed suction system
- DEVICE
-
Halyard
Halyard Closed Suction System
Sponsors & Collaborators
-
Teleflex
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Neil MacIntyre · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-17
- Primary Completion
- 2020-04-17
- Completion
- 2020-04-17
Countries
- United States
Study Locations
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