- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01587157
Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)
April 25, 2012 updated by: Technical University of Munich
Capnography provides noninvasive monitoring of ventilation and can allow early recognition of altered respiration patterns and apnea.
The aim of this prospective study was to compare the detection of apnea and the prediction of oxygen desaturation and hypoxemia by capnography versus clinical surveillance during procedural sedation for percutaneous transhepatic cholangiodrainage (PTCD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
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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Bavaria
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Munich, Bavaria, Germany, 81675
- Klinikum rechts der Isar
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age>=18
- Scheduled for PTCD with midazolam and propofol sedation
Exclusion Criteria:
- age less than 18 years
- ASA class V
- allergy to narcotic drugs
- pregnancy
- pre-existing hypotension, bradycardia or hypoxemia
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: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: capnography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)
|
Secondary Outcome Measures
Outcome Measure |
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overall number of detected episodes of apnea
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the occurrences of oxygen desaturation and hypoxemia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2010
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
April 23, 2012
First Submitted That Met QC Criteria
April 25, 2012
First Posted (ESTIMATE)
April 30, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 30, 2012
Last Update Submitted That Met QC Criteria
April 25, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20042012
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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