Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Phase 3

Completed

• Conditions: Apnea; Hypoxemia; Complications

• Registration Number: NCT01587157
• Lead Sponsor: Technical University of Munich

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-25
• Last Update Submitted: 2012-04-25
• Study First Posted: 2012-04-30
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
mean cumulative duration of detected apnea episodes per patient (capnographic vs. clinical surveillance)

Secondary Outcome Measures

Name	Time	Method
overall number of detected episodes of apnea
the occurrences of oxygen desaturation and hypoxemia

Trial Locations

Locations (1)

Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany