Text Size

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
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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:
    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

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

No publications provided

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
Study First Received: April 18, 2008
Last Updated: May 28, 2008
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

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

ClinicalTrials.gov processed this record on May 19, 2013