EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

Not Applicable

Terminated

• Conditions: Endotracheal Tube Clearance
• Interventions: Device: Cleansweep; Device: Halyard

• Registration Number: NCT03486002
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-03
• Study Start: 2018-07-17
• Status Verified: 2019-09
• Primary Completion: 2020-04-17
• Study Completion: 2020-04-17
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cleansweep closed suction system	Cleansweep	-
Halyard closed suction system	Halyard	-

Primary Outcome Measures

Name	Time	Method
Change in endotracheal tube resistance during mechanical ventilation after 4 suction procedures	8 hours	Measurements of resistance will be made following each suction procedure (2 with the Cleansweep system and 2 with the standard system)

Trial Locations

Locations (1)

Duke Health System; 🇺🇸 Durham, North Carolina, United States