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NCT01587157 Clinical Trial

Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Hypoxemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01587157
Other study ID # 20042012
Secondary ID
Status Completed
Phase Phase 3
First received April 23, 2012
Last updated April 25, 2012
Start date August 2010
Est. completion date August 2011

Study information
Verified date April 2012
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2011
Est. primary completion date June 2011
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• capnography

Locations
Country Name City State
Germany Klinikum rechts der Isar Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)
Secondary overall number of detected episodes of apnea
Secondary the occurrences of oxygen desaturation and hypoxemia
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