EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

NCT ID: NCT03486002

Last Updated: 2020-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2020-04-17

Brief Summary

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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

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Conditions

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Endotracheal Tube Clearance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cleansweep closed suction system

Group Type OTHER

Cleansweep

Intervention Type DEVICE

The Cleansweep closed suction system

Halyard closed suction system

Group Type OTHER

Halyard

Intervention Type DEVICE

Halyard Closed Suction System

Interventions

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Cleansweep

The Cleansweep closed suction system

Intervention Type DEVICE

Halyard

Halyard Closed Suction System

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teleflex

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil MacIntyre

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Health System

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00087066

Identifier Type: -

Identifier Source: org_study_id

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