Text Size

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

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01060709
First received: February 1, 2010
Last updated: October 25, 2010
Last verified: November 2009
History of Changes
  Purpose

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?


Condition
Colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Transcutaneous Carbon Dioxide Partial Pressure (TcCO2) Monitoring Detect Hypoventilation Prior to Current Sedation Monitoring Practices?

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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? [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
elective colonoscopy and requiring sedation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing elective colonoscopy and requiring sedation

Criteria

Inclusion Criteria:

  • Patients requiring sedation for colonoscopy

Exclusion Criteria:

  • Patient refusal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060709

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713EZ
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Study Director: J K Oosterhuis, Drs University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: J.K.Oosterhuis, University Medical Center Groningen,
ClinicalTrials.gov Identifier: NCT01060709     History of Changes
Other Study ID Numbers: TcCo2-001
Study First Received: February 1, 2010
Last Updated: October 25, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
Carbon dioxide
TcC02
Hypoventilation
endoscopic
elective colonoscopy and requiring sedation

Additional relevant MeSH terms:
Hypoventilation
Respiratory Insufficiency
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013