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Removal of Endotracheal Tube Secretions Comprehensively Until Extubation

NCT ID: NCT00663637

Last Updated: 2008-05-29

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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The purpose of this study is to measure secretion accumulation within endotracheal tubes of mechanically ventilated patients and test the efficacy, safety and clinical impact of removing the secretions using novel airway management catheters (Complete Airway Management Catheters: CAM Rescue Cath and CAM Endotrach Cath).

Detailed Description

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Thirty mechanically ventilated adult patients will be managed with standard suction catheters. Just prior to extubation, their physiological parameters (including work of breathing) will be recorded and acoustic reflectometry used to measure the degree of secretion accumulation within the endotracheal tube. The endotracheal tubes will then be cleaned using the CAM Catheters (Rescue Cath followed by Endotrach Cath) and the physiological parameters and endotracheal tube reflectometry measurements repeated for comparative analysis.

Conditions

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Mechanical Ventilation Pneumonia

Keywords

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endotracheal tube obstruction, occlusion mechanical ventilation, complication work of breathing airway resistance secretions pneumonia, ventilator associated biofilms endotracheal tube

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CAM (Complete Airway Management) Catheters

Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.

Intervention Type DEVICE

Other Intervention Names

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CAM Rescue Cath CAM Endotrach Cath

Eligibility Criteria

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Inclusion Criteria

* Patients receiving medical care in adult intensive care unit setting
* Patients who have been intubated and mechanically ventilated for at least 12 hours
* Patients intubated with an endotracheal tube with an internal diameter of 7.0 mm or greater

Exclusion Criteria

* Patients receiving medical care in a setting not compatible with an adult intensive care unit
* Patients who have been intubated and mechanically ventilated for less than 12 hours
* Patients intubated with an endotracheal tube with an internal diameter of 6.5 mm or less
* Patients intubated with dual lumen or steel-reinforced endotracheal tubes
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Francis Medical Center

UNKNOWN

Sponsor Role collaborator

Statistical Consulting

UNKNOWN

Sponsor Role collaborator

O. M. Neotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Saint Francis Medical Center

Principal Investigators

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Orlando V. Morejon, MD

Role: STUDY_DIRECTOR

Saint Francis Medical Center; Omneotech

Locations

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Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Robert H. Stone, RRT

Role: CONTACT

Phone: 573-331-3000

Email: [email protected]

Stephen S. Bricknell, RRT

Role: CONTACT

Phone: 573-331-3000

Email: [email protected]

Other Identifiers

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CAM-0801

Identifier Type: -

Identifier Source: org_study_id