Capnographic Monitoring of Propofol-sedation During Colonoscopy

Hypoxia Clinical Trial

Official title:

Capnographic Monitoring of Propofol-sedation During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638793
• Other study ID #: JWGUHMED1-006
• Status: Completed
• Phase: N/A
• First received: July 11, 2012
• Last updated: October 24, 2013
• Start date: June 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2012
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for colonoscopy

• Patient wishing sedation during colonoscopy

• = 18 years of age

• Signed informed consent form

Exclusion Criteria:

• Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)

• Non-contractually capable persons

• Pregnancy

• Lactation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Hypoxia

Intervention

Device:
• Microcap (Oridion, Needham, MA, USA)

• Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)

Locations

Country	Name	City	State
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt am Main
Germany	Praxisklinik am Staedel	Frankfurt am Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxia (SO2 <90%)	Study objective is to evaluate if a reduction of hypoxic events (SO2 <90% for = 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation		Yes
Secondary	Severe Hypoxia (SO2 <85%)	Evaluate events of severe hypoxia (SO2 < 85%) in group 1 (capnographic monitoring) as compared to group 2 (oxymetric monitoring)		Yes
Secondary	Time to hypoxia	Evaluate the time difference between abnormal ventilation shown on capnography machine and hypoxemia.		Yes
Secondary	Hypoxia in relation to sedation	Compare events of hypoxemia and severe hypoxemia during sedation with propofol only as compared to propofol/ketamin combination sedation.		Yes
Secondary	Vegetative Symptoms	Evaluate vegetative events (hypotension, hypertension, bradycardia, tachycardia, tachypnea, bradypnea) in both groups during the two sedation forms		Yes