Removal of Endotracheal Tube Secretions Comprehensively Until Extubation

Phase 2

• Conditions: Mechanical Ventilation; Pneumonia

• Registration Number: NCT00663637
• Lead Sponsor: O. M. Neotech, Inc.

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.

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Last Update Submitted: 2008-05-28
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
work of breathing	pre-extubation

Secondary Outcome Measures

Name	Time	Method
endotracheal tube patency	pre-extubation

Trial Locations

Locations (1)

Saint Francis Medical Center; 🇺🇸 Cape Girardeau, Missouri, United States