Capnography During Upper GI Endoscopy | NCT01242345

Studies
Capnography During Upper GI Endoscopy

NCT01242345

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Nov 22, 2011Estimated

Enrollment

170Actual

Phase

Phase 3

Conditions

Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy

Interventions

Capnography

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 16, 2010

First Submission Date that Met QC Criteria

Nov 16, 2010

First Posted Date

Nov 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Riphaus, Capnography During Upper GI Endoscopy, Ruhr University of BochumPrincipal Investigator

Lead Sponsor

Ruhr University of BochumOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this randomized controlled trial the utility of capnography and IPI 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No Intervention	No Intervention	Standard monitoring.
Capnography	Experimental	Arm with capnographic monitoring	Device: Capnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capnography	Device	Monitoring of the capnography curve for early detection of apnea	Capnography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypoxemia		From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Secondary Outcomes

Measure	Description	Time Frame
Further complications		From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age>=18
Scheduled for interventional upper GI endoscopy with midazolam and propofol sedation

Exclusion Criteria:

No informed consent
ASA IV or V
Emergency endoscopy
Preexisting hypotension, bradycardia or hypoxemia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruhr Universität Bochum		Bochum		44892	Germany
Technische Universität München

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19422079	Background	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.

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012129	Respiratory Function Tests
D003948	Diagnostic Techniques, Respiratory System
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis