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

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Klinikum rechts der Isar

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
Procedure: 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
overall number of detected episodes of apnea
the occurrences of oxygen desaturation and hypoxemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

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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