Capnography During Upper GI Endoscopy

Sponsor

Ruhr University of Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT01242345

Collaborator

(none)

170

Enrollment

Locations

Arms

Duration (Months)

56.7

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Capnography as an Adjunct to Standard Monitoring During Midazolam and Propofol Sedation for Interventional Upper GI Endoscopy	Device: Capnography	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Clinical Value of Advanced Patient Monitoring With Capnography and Analysis of the Integrated Pulmonary Index During Interventional Upper Gastrointestinale Endoscopy

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Intervention Standard monitoring.
Experimental: Capnography Arm with capnographic monitoring	Device: Capnography Monitoring of the capnography curve for early detection of apnea

Arm

Intervention/Treatment

No Intervention: No Intervention

Standard monitoring.

Experimental: Capnography

Arm with capnographic monitoring

Device: Capnography

Monitoring of the capnography curve for early detection of apnea

Outcome Measures

Primary Outcome Measures

Hypoxemia [From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h]

Secondary Outcome Measures

Further complications [From the start to the end of endoscopy, i.e. from 0 h to approximately 2 h]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ruhr Universität Bochum	Bochum	Germany	44892
2	Technische Universität München	München	Germany	81675
3	Deutsche Klinik für Diagnostik	Wiesbaden	Germany	65191

Sponsors and Collaborators

Ruhr University of Bochum

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Andrea Riphaus, Capnography During Upper GI Endoscopy, Ruhr University of Bochum

ClinicalTrials.gov Identifier:

NCT01242345

Other Study ID Numbers:

Capno-Interventional 2011

First Posted:

Nov 17, 2010

Last Update Posted:

Nov 22, 2011

Last Verified:

Nov 1, 2010

Keywords provided by Andrea Riphaus, Capnography During Upper GI Endoscopy, Ruhr University of Bochum

Hypoxemia

Capnography

Integrated pulmonary index

Sedation

Propofol

Safety

Study Results

No Results Posted as of Nov 22, 2011