EFFEXTS OF THE CLEANSWEEP SUCTION CATHETER

EFFECTS OF TELEFLEX CATHETER (CLEANSWEEP) ON VENTILATOR MECHANICS

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.

Study Overview

• Status: Terminated
• Conditions: Endotracheal Tube Clearance
• Intervention / Treatment: Device: Cleansweep; Device: Halyard

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cleansweep closed suction system	Device: Cleansweep; The Cleansweep closed suction system
OTHER: Halyard closed suction system	Device: Halyard; Halyard Closed Suction System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Teleflex
• Investigators: Principal Investigator: Neil MacIntyre, Duke University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2018
• Primary Completion (ACTUAL): April 17, 2020
• Study Completion (ACTUAL): April 17, 2020

Study Registration Dates

• First Submitted: March 27, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (ACTUAL): April 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 21, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00087066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No