Capnography During ERCP (EndoBreath)

Technical University of Munich

Status and phase: Completed; Phase 3

Conditions: Complications; Hypoxemia

Treatments: Procedure: Capnography; Procedure: Standard monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01072474

2680/10

Details and patient eligibility

About

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

Full description

In this randomized controlled trial the utility of capnography 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.

Enrollment: 242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>=18
• Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion criteria

• No informed consent
• ASA V
• Pregnancy
• Prexisting hypotension, bradycardia or hypoxemia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups, including a placebo group

Capnography

Experimental group

Description:

Arm with capnographic monitoring

Treatment:

Procedure: Capnography

Standard

Placebo Comparator group

Description:

Standard monitoring.

Treatment:

Procedure: Standard monitoring