Removal of Endotracheal Tube Secretions Comprehensively Until Extubation - Full Text View

Sponsors and Collaborators:	O. M. Neotech, Inc. Saint Francis Medical Center Statistical Consulting
Information provided by:	O. M. Neotech, Inc.
ClinicalTrials.gov Identifier:	NCT00663637

Purpose

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).

Condition	Intervention	Phase
Mechanical Ventilation Pneumonia	Device: CAM (Complete Airway Management) Catheters	Phase II

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study

Further study details as provided by O. M. Neotech, Inc.:

Primary Outcome Measures:

work of breathing [ Time Frame: pre-extubation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

endotracheal tube patency [ Time Frame: pre-extubation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2008

Intervention Details:

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

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663637

Contacts

Contact: Robert H. Stone, RRT	573-331-3000 ext 6393	bstone@sfmc.net
Contact: Stephen S. Bricknell, RRT	573-331-3000 ext 6393	sbricknell@sfmc.net

Locations

United States, Missouri
Saint Francis Medical Center	Recruiting
Cape Girardeau, Missouri, United States, 63703
Principal Investigator: Robert H. Stone, RRT
Principal Investigator: Stephen S. Bricknell, RRT
Sub-Investigator: Orlando V. Morejon, MD

Sponsors and Collaborators

O. M. Neotech, Inc.

Saint Francis Medical Center

Statistical Consulting

Investigators

Study Director:

Orlando V. Morejon, MD

Saint Francis Medical Center; Omneotech

More Information

Responsible Party:	Saint Francis Medical Center ( Robert Stone RRT; Stephen Bricknell RRT )
Study ID Numbers:	CAM-0801
Study First Received:	April 18, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00663637
Health Authority:	United States: Institutional Review Board

Keywords provided by O. M. Neotech, Inc.:

endotracheal tube obstruction, occlusion
mechanical ventilation, complication
work of breathing
airway resistance

secretions
pneumonia, ventilator associated
biofilms
endotracheal tube

Study placed in the following topic categories:

Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia, Ventilator-Associated
Pneumonia

ClinicalTrials.gov processed this record on January 16, 2009