- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00866255
Continuous Measurement of Intratracheal Pressure
February 1, 2010 updated by: University Hospital Freiburg
Continuous Measurement of Intratracheal Pressure in Mechanically Ventilated Infants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
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
-
-
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Freiburg, Germany, 79106
- University Medical Center Freiburg
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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
1 day to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children < 10 Years
- volume-controlled ventilation
Exclusion Criteria:
- refusal of written informed consent
- severe pulmonary diseases
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: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
tracheal pressure
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guttmann J, Kessler V, Mols G, Hentschel R, Haberthur C, Geiger K. Continuous calculation of intratracheal pressure in the presence of pediatric endotracheal tubes. Crit Care Med. 2000 Apr;28(4):1018-26. doi: 10.1097/00003246-200004000-00018.
- 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. doi: 10.1097/00000542-199309000-00014.
- Spaeth J, Steinmann D, Kaltofen H, Guttmann J, Schumann S. The pressure drop across the endotracheal tube in mechanically ventilated pediatric patients. Paediatr Anaesth. 2015 Apr;25(4):413-20. doi: 10.1111/pan.12595. Epub 2014 Dec 10.
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
January 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 19, 2009
First Submitted That Met QC Criteria
March 19, 2009
First Posted (Estimate)
March 20, 2009
Study Record Updates
Last Update Posted (Estimate)
February 2, 2010
Last Update Submitted That Met QC Criteria
February 1, 2010
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 237/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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