Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome (PACSO)

Technical University of Munich

Status: Completed

Conditions: Sedation Problems; Breathing Complications

Treatments: Procedure: Position the patient during colonoscopy; Device: pulse oximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT02001792

PatPo2012

Details and patient eligibility

About

The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

Full description

Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.

Enrollment: 412 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• colonoscopy indicated

Exclusion criteria

• patient denies sedation
• prior saturation < 90%
• prior heart rate < 50 bpm
• prior blood pressure < 90 mmHg

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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412 participants in 2 patient groups

Controll group

Sham Comparator group

Description:

Patients lying in a supine position during colonoscopy

Treatment:

Device: pulse oximeter

Intervention

Active Comparator group

Description:

Patients lying in a left lateral position during colonoscopy

Treatment:

Device: pulse oximeter

Procedure: Position the patient during colonoscopy