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Removal of Endotracheal Tube Secretions Comprehensively Until Extubation (RESCUE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by O. M. Neotech, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00663637
First Posted: April 22, 2008
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Saint Francis Medical Center
Statistical Consulting
Information provided by:
O. M. Neotech, Inc.
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • endotracheal tube patency [ Time Frame: pre-extubation ]

Estimated Enrollment: 30
Study Start Date: April 2008
Intervention Details:
    Device: CAM (Complete Airway Management) Catheters
    Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.
    Other Names:
    • CAM Rescue Cath
    • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Robert Stone RRT; Stephen Bricknell RRT, Saint Francis Medical Center
ClinicalTrials.gov Identifier: NCT00663637     History of Changes
Other Study ID Numbers: CAM-0801
First Submitted: April 18, 2008
First Posted: April 22, 2008
Last Update Posted: May 29, 2008
Last Verified: April 2008

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections


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