Continuous Measurement of Intratracheal Pressure

This study is currently recruiting participants.

Verified by University Hospital Freiburg, March 2009

First Received: March 19, 2009 No Changes Posted

Sponsored by:	University Hospital Freiburg
Information provided by:	University Hospital Freiburg
ClinicalTrials.gov Identifier:	NCT00866255

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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	Recruiting
Freiburg, Germany, 79106
Contact: Daniel Steinmann, MD 0049 761 270 2329 daniel.steinmann@uniklinik-freiburg.de

Sponsors and Collaborators

University Hospital Freiburg

More Information

Publications:

Guttmann J, Kessler V, Mols G, Hentschel R, Haberthür C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26.

Guttmann J, Eberhard L, Fabry B, Bertschmann W, Wolff G. Continuous calculation of intratracheal pressure in tracheally intubated patients. Anesthesiology. 1993 Sep;79(3):503-13.

Responsible Party:	University Medical Center Freiburg ( Dr. med. Daniel Steinmann )
Study ID Numbers:	237/06
Study First Received:	March 19, 2009
Last Updated:	March 19, 2009
ClinicalTrials.gov Identifier:	NCT00866255 History of Changes
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 May 07, 2009