NCT01072474

Brief Summary

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 24, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

February 18, 2010

Last Update Submit

August 23, 2012

Conditions

HypoxemiaComplications

Keywords

SafetySedationGastrointestinal endoscopyColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

    From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Secondary Outcomes (1)

  • Further complications

    From the beginning to the end of the ERCP procedure, i.e. from 0h to approximately 2h

Study Arms (2)

Capnography

EXPERIMENTAL

Arm with capnographic monitoring

Procedure: Capnography

Standard

PLACEBO COMPARATOR

Standard monitoring.

Procedure: Standard monitoring

Interventions

CapnographyPROCEDURE

Capnographic monitoring

Capnography
Standard monitoringPROCEDURE

Standard monitoring

Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Technische Universität München

Munich, Bavaria, 81675, Germany

Location

Knappschaftskrankenhaus der Ruhr-Universität Bochum

Bochum, 44892, Germany

Location

Deutsche Klinik für Diagnostik

Wiesbaden, 65191, Germany

Location

Related Publications (2)

  • 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.

    PMID: 19422079BACKGROUND

  • Klare P, Reiter J, Meining A, Wagenpfeil S, Kronshage T, Geist C, Heringlake S, Schlag C, Bajbouj M, Schneider G, Schmid RM, Wehrmann T, von Delius S, Riphaus A. Capnographic monitoring of midazolam and propofol sedation during ERCP: a randomized controlled study (EndoBreath Study). Endoscopy. 2016 Jan;48(1):42-50. doi: 10.1055/s-0034-1393117. Epub 2015 Sep 28.

    PMID: 26415090DERIVED

Related Links

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan von Delius, MD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2012

Last Updated

August 24, 2012

Record last verified: 2012-08

Locations

DE(3)