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Removal of Endotracheal Tube Secretions Comprehensively Until Extubation (RESCUE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by O. M. Neotech, Inc..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Saint Francis Medical Center
Statistical Consulting
Information provided by:
O. M. Neotech, Inc.
ClinicalTrials.gov Identifier:
NCT00663637
First received: April 18, 2008
Last updated: May 28, 2008
Last verified: April 2008

April 18, 2008
May 28, 2008
April 2008
Not Provided
work of breathing [ Time Frame: pre-extubation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00663637 on ClinicalTrials.gov Archive Site
endotracheal tube patency [ Time Frame: pre-extubation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study

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).

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Mechanical Ventilation
  • Pneumonia
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
Not Provided

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
Both
Not Provided
No
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
 
NCT00663637
CAM-0801
No
Robert Stone RRT; Stephen Bricknell RRT, Saint Francis Medical Center
O. M. Neotech, Inc.
  • Saint Francis Medical Center
  • Statistical Consulting
Study Director: Orlando V. Morejon, MD Saint Francis Medical Center; Omneotech
O. M. Neotech, Inc.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP