Recruiting
Phase 2

Observational Study

Sponsor:

O. M. Neotech, Inc.

Code:

NCT00663637

Conditions

Mechanical Ventilation

Pneumonia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

CAM (Complete Airway Management) Catheters

Study Details

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).

Conditions

Mechanical Ventilation

Pneumonia

Study ID

NCT00663637

Start date

Apr, 2008

Status verified date

Apr, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

CAM (Complete Airway Management) Catheters

Prior to extubation, endotracheal tube lumen secretions are mechanically removed using CAM Rescue Cath followed by CAM Endotrach Cath.

Primary outcome measure

  • work of breathing [ Time Frame: pre-extubation ]

Central Contacts and Locations

Central contacts

Robert H. Stone, RRT

573-331-3000bstone@sfmc.net

Stephen S. Bricknell, RRT

573-331-3000sbricknell@sfmc.net

Locations

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Principal Investigator:

Robert H. Stone, RRT

More Information

Sponsor

O. M. Neotech, Inc.

Last update posted

May 29, 2008

Last verified

Apr, 2008

Keywords

  • endotracheal tube obstruction, occlusion
  • mechanical ventilation, complication
  • work of breathing
  • airway resistance
  • secretions
  • pneumonia, ventilator associated
  • biofilms
  • endotracheal tube

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by O. M. Neotech, Inc. on 2008-05-29.