Capnography During Colonoscopy (ColoCap)

This study has been completed.

Sponsor:

Information provided by:

Technische Universität München

ClinicalTrials.gov Identifier:

NCT01072487

First received: February 17, 2010

Last updated: February 2, 2011

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2010

Last Updated Date

February 2, 2011

Start Date ^ICMJE

February 2010

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Hypoxemia [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01072487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Further complications [ Time Frame: From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Capnography During Colonoscopy

Official Title ^ICMJE

Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Colonoscopy

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Condition ^ICMJE

Hypoxemia
Complications

Intervention ^ICMJE

Procedure: Capnography

Monitoring of the capnography curve for early detection of apnea

Study Arm (s)

Experimental: Capnography
Arm with capnographic monitoring

Intervention: Procedure: Capnography
No Intervention: Standard
Standard monitoring.

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

760

Completion Date

Not Provided

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01072487

Other Study ID Numbers ^ICMJE

2681/10

Has Data Monitoring Committee

Responsible Party

Stefan von Delius, II. Medizinische Klinik der Technischen Universität München

Study Sponsor ^ICMJE

Technische Universität München

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stefan von Delius, MD

Technische Universität München

Information Provided By

Technische Universität München

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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