Removal of Endotracheal Tube Secretions Comprehensively Until Extubation (RESCUE)

May 28, 2008 updated by: O. M. Neotech, Inc.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: CAM (Complete Airway Management) Catheters

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Recruiting
    - Saint Francis Medical Center
    - Principal Investigator:
      
      Robert H. Stone, RRT
    - Principal Investigator:
      
      Stephen S. Bricknell, RRT
    - Sub-Investigator:
      
      Orlando V. Morejon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
work of breathing Time Frame: pre-extubation	pre-extubation

Secondary Outcome Measures

Outcome Measure	Time Frame
endotracheal tube patency Time Frame: pre-extubation	pre-extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

O. M. Neotech, Inc.

Collaborators

Saint Francis Medical Center

Statistical Consulting

Investigators

Study Director: Orlando V. Morejon, MD, Saint Francis Medical Center; Omneotech

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 21, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified