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Removal of Endotracheal Tube Secretions Comprehensively Until Extubation (RESCUE)

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ClinicalTrials.gov Identifier: NCT00663637
Recruitment Status : Unknown
Verified April 2008 by O. M. Neotech, Inc..
Recruitment status was:  Recruiting
First Posted : April 22, 2008
Last Update Posted : May 29, 2008
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Mechanical Ventilation Pneumonia Device: CAM (Complete Airway Management) Catheters Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : April 2008
Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. work of breathing [ Time Frame: pre-extubation ]

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

Eligibility Criteria

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

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

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

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
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 Posted: April 22, 2008    Key Record Dates
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
pneumonia, ventilator associated
endotracheal tube

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