Text Size

Continuous Measurement of Intratracheal Pressure

This study has been completed.
Sponsor:
Information provided by:
University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT00866255
First received: March 19, 2009
Last updated: February 1, 2010
Last verified: March 2009
History of Changes
  Purpose

Continuous measurement of intratracheal pressure in mechanically ventilated infants using a fibreoptic pressure transducer in the endotracheal tube (ETT). Based on the findings, tracheal pressure can continuously be monitored in the presence of pediatric ETTs by combining ETT coefficients and the flow and airway pressure continuously measured at the proximal end of the ETT.


Condition Intervention
Endotracheal Pressure
 Device: endotracheal tube pressure measurement probe

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Continuous Measurement of Intratracheal Pressure in Mechanically Ventilated Infants

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • tracheal pressure [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: endotracheal tube pressure measurement probe
    The endotracheal tube pressure measurement probe is inserted into the endotracheal tube prior to intubation for measurement of tracheal pressure at the tip of the endotracheal tube.
  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children < 10 Years
  • volume-controlled ventilation

Exclusion Criteria:

  • refusal of written informed consent
  • severe pulmonary diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866255

Locations
Germany
University Medical Center Freiburg
Freiburg, Germany, 79106
Sponsors and Collaborators
University Hospital Freiburg
  More Information

Publications:

Responsible Party: Dr. med. Daniel Steinmann, University Medical Center Freiburg
ClinicalTrials.gov Identifier: NCT00866255     History of Changes
Other Study ID Numbers: 237/06
Study First Received: March 19, 2009
Last Updated: February 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
endotracheal tube
endotracheal pressure
airway pressure
 pressure drop
calculation
continuous calculation

ClinicalTrials.gov processed this record on June 18, 2013