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NCT00663637 Clinical Trial

Removal of Endotracheal Tube Secretions Comprehensively Until Extubation

Pneumonia Clinical Trial

— RESCUE  

Official title:
Evaluation of the Safety and Efficacy of CAM (Complete Airway Management) Catheters: Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00663637
Other study ID # CAM-0801
Secondary ID
Status Recruiting
Phase Phase 2
First received April 18, 2008
Last updated May 28, 2008
Start date April 2008

Study information
Verified date April 2008
Source O. M. Neotech, Inc.
Contact Robert H. Stone, RRT
Phone 573-331-3000
Email bstone@sfmc.net
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Saint Francis Medical Center Cape Girardeau Missouri

Sponsors (3)
Lead Sponsor Collaborator
O. M. Neotech, Inc. Saint Francis Medical Center, Statistical Consulting

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary work of breathing pre-extubation Yes
Secondary endotracheal tube patency pre-extubation Yes
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