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Capnography During Colonoscopy (ColoCap)

Primary Purpose

Hypoxemia, Complications

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Capnography
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypoxemia focused on measuring Safety, Sedation, Gastrointestinal endoscopy, Colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No informed consent
  • ASA IV or V
  • Pregnancy
  • Prexisting hypotension, bradycardia or hypoxemia

Sites / Locations

  • Technische Universität München
  • Knappschaftskrankenhaus der Ruhr-Universität Bochum
  • Deutsche Klinik für Diagnostik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Capnography

Standard

Arm Description

Arm with capnographic monitoring

Standard monitoring.

Outcomes

Primary Outcome Measures

Hypoxemia

Secondary Outcome Measures

Further complications

Full Information

First Posted
February 17, 2010
Last Updated
February 2, 2011
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01072487
Brief Title
Capnography During Colonoscopy
Acronym
ColoCap
Official Title
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In the study the value of capnography for avoiding complications during sedation for colonoscopy is evaluated.
Detailed Description
In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia, Complications
Keywords
Safety, Sedation, Gastrointestinal endoscopy, Colonoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capnography
Arm Type
Experimental
Arm Description
Arm with capnographic monitoring
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Standard monitoring.
Intervention Type
Procedure
Intervention Name(s)
Capnography
Intervention Description
Monitoring of the capnography curve for early detection of apnea
Primary Outcome Measure Information:
Title
Hypoxemia
Time Frame
From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h
Secondary Outcome Measure Information:
Title
Further complications
Time Frame
From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age>=18 Scheduled for colonoscopy with midazolam and propofol sedation Exclusion Criteria: No informed consent ASA IV or V Pregnancy Prexisting hypotension, bradycardia or hypoxemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität München
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Knappschaftskrankenhaus der Ruhr-Universität Bochum
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19422079
Citation
Qadeer MA, Vargo JJ, Dumot JA, Lopez R, Trolli PA, Stevens T, Parsi MA, Sanaka MR, Zuccaro G. Capnographic monitoring of respiratory activity improves safety of sedation for endoscopic cholangiopancreatography and ultrasonography. Gastroenterology. 2009 May;136(5):1568-76; quiz 1819-20. doi: 10.1053/j.gastro.2009.02.004.
Results Reference
background
Links:
URL
http://www.med2.med.tu-muenchen.de/
Description
II. Medizinische Klinik der Technischen Universität München

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Capnography During Colonoscopy

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