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NCT01060709 Clinical Trial

Transcutaneous Measurement of Carbon Dioxide Versus Current Sedation Practices in Sedated Patients

Colonoscopy Clinical Trial

Official title:
Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01060709
Other study ID # TcCo2-001
Secondary ID
Status Completed
Phase N/A
First received February 1, 2010
Last updated October 25, 2010
Start date December 2009
Est. completion date September 2010

Study information
Verified date November 2009
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients requiring sedation for colonoscopy

Exclusion Criteria:

- Patient refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)
Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Does transcutaneous carbon dioxide partial pressure (TcCO2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies? one year No
Secondary To verify if there is an association with the following variables: age, gender, weight, length, ASA-classification, sedation depth (BIS), co-morbidity, diagnostic or therapeutic colonoscopy. one year No
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