Capnographic Monitoring of Propofol-sedation During Colonoscopy

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Hypoxia

Treatments: Device: Smart Capno Line Plus O2 (Oridion, Needham, MA, USA); Device: Microcap (Oridion, Needham, MA, USA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01638793

JWGUHMED1-006

Details and patient eligibility

About

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.

Enrollment: 528 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

528 participants in 2 patient groups

Capnography

Experimental group

Description:

Capnographic respiration monitoring

Treatment:

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

Pulse-Oxymetry

Active Comparator group

Description:

pulse-oxymetric respiration monitoring

Treatment:

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