Back to resultsRemoval of Endotracheal Tube Secretions Comprehensively Until Extubation (RESCUE)
Primary Purpose
Mechanical Ventilation, Pneumonia
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CAM (Complete Airway Management) Catheters
Sponsored by
About this trial
This is an interventional treatment trial for Mechanical Ventilation focused on measuring endotracheal tube obstruction, occlusion, mechanical ventilation, complication, work of breathing, airway resistance, secretions, pneumonia, ventilator associated, biofilms, endotracheal tube
Eligibility 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
Sites / Locations
- Saint Francis Medical CenterRecruiting
Outcomes
Primary Outcome Measures
work of breathing
Secondary Outcome Measures
endotracheal tube patency
Full Information
NCT ID
NCT00663637
First Posted
April 18, 2008
Last Updated
May 28, 2008
Sponsor
O. M. Neotech, Inc.
Collaborators
Saint Francis Medical Center, Statistical Consulting
1. Study Identification
Unique Protocol Identification Number
NCT00663637
Brief Title
Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
Acronym
RESCUE
Official Title
Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
O. M. Neotech, Inc.
Collaborators
Saint Francis Medical Center, Statistical Consulting
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Ventilation, Pneumonia
Keywords
endotracheal tube obstruction, occlusion, mechanical ventilation, complication, work of breathing, airway resistance, secretions, pneumonia, ventilator associated, biofilms, endotracheal tube
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CAM (Complete Airway Management) Catheters
Other Intervention Name(s)
CAM Rescue Cath, CAM Endotrach Cath
Intervention Description
Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.
Primary Outcome Measure Information:
Title
work of breathing
Time Frame
pre-extubation
Secondary Outcome Measure Information:
Title
endotracheal tube patency
Time Frame
pre-extubation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert H. Stone, RRT
Phone
573-331-3000
Ext
6393
Email
bstone@sfmc.net
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen S. Bricknell, RRT
Phone
573-331-3000
Ext
6393
Email
sbricknell@sfmc.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orlando V. Morejon, MD
Organizational Affiliation
Saint Francis Medical Center; Omneotech
Official's Role
Study Director
Facility Information:
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert H. Stone, RRT
First Name & Middle Initial & Last Name & Degree
Stephen S. Bricknell, RRT
First Name & Middle Initial & Last Name & Degree
Orlando V. Morejon, MD
12. IPD Sharing Statement
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Removal of Endotracheal Tube Secretions Comprehensively Until Extubation
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