CClinicalTrials.gg
Sign In
CompletedNCT01587157Updated Apr 30, 2012

Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

A Phase 3 interventional study of capnography in Apnea, Hypoxemia and Complications, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-30.

Sponsored by Technical University of Munich · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Apnea
  • Hypoxemia
  • Complications

Browse trials for

03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • Age>=18
  • Scheduled for PTCD with midazolam and propofol sedation

Exclusion criteria

Exclusion Criteria:

  • age less than 18 years
  • ASA class V
  • allergy to narcotic drugs
  • pregnancy
  • pre-existing hypotension, bradycardia or hypoxemia
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Enrollment
20 participants (actual)

Study arms

  • Experimental
    capnography

    Procedure: capnography

Interventions

  • Procedurecapnography
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. overall number of detected episodes of apnea

  2. the occurrences of oxygen desaturation and hypoxemia

07

Study locations

1 site
  • Klinikum rechts der Isar
    Munich, Bavaria 81675, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01587157
Lead sponsor
Technical University of Munich
Responsible party
Sponsor
First posted
Apr 30, 2012
Start date
Aug 2010
Primary completion
Jun 2011
Completion
Aug 2011
Last update
Apr 30, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypoxia→

Other studies from this sponsor

Technical University of Munich

Start the discussion