NCT01072487

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
760

participants targeted

Target at P75+ for phase_3

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
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
5 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
Last Updated

February 3, 2011

Status Verified

February 1, 2011

Enrollment Period

1 year

First QC Date

February 17, 2010

Last Update Submit

February 2, 2011

Conditions

HypoxemiaComplications

Keywords

SafetySedationGastrointestinal endoscopyColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Hypoxemia

    From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

Secondary Outcomes (1)

  • Further complications

    From the start to the end of colonoscopy, i.e. from 0 h to approximately 2 h

Study Arms (2)

Capnography

EXPERIMENTAL

Arm with capnographic monitoring

Procedure: Capnography

Standard

NO INTERVENTION

Standard monitoring.

Interventions

CapnographyPROCEDURE

Monitoring of the capnography curve for early detection of apnea

Capnography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
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 IV or 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 (1)

  • 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

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 17, 2010

First Posted

February 22, 2010

Study Start

February 1, 2010

Primary Completion

February 1, 2011

Last Updated

February 3, 2011

Record last verified: 2011-02

Locations

DE(3)