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Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Primary Purpose

Apnea, Hypoxemia, Complications

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

capnography

About this trial

This is an interventional prevention trial for Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

capnography

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

overall number of detected episodes of apnea

the occurrences of oxygen desaturation and hypoxemia

Full Information

NCT ID

NCT01587157

First Posted

April 23, 2012

Last Updated

April 25, 2012

Sponsor

Technical University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT01587157

Brief Title

Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technical University of Munich

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Apnea, Hypoxemia, Complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

capnography

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

capnography

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

overall number of detected episodes of apnea

Title

the occurrences of oxygen desaturation and hypoxemia

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

Facility Information:

Facility Name

Klinikum rechts der Isar

City

Munich

State/Province

Bavaria

ZIP/Postal Code

81675

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Capnography During Percutaneous Transhepatic Cholangiodrainage (PTCD) (HepaBreath)

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