A Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position

A Randomized Controlled Trial Comparing High-flow Nasal Oxygen With Standard Management for Conscious Sedation During Endoscopic Retrograde Cholangiopancreatography in Prone Position

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03872674

Enrollment

Registered

2019-03-13

Start date

2019-04-01

Completion date

2019-04-18

Last updated

2019-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position

Brief summary

Traditional conscious sedation for endoscopic retrograde cholangiopancreatography in prone position places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic retrograde cholangiopancreatography. The investigators will compare the lowest SpO2 of standard nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.

Interventions

BIOLOGICALhigh-flow humidified oxygen-delivery system (OptiFlow THRIVE)

stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Masking description

Patients will be randomly allocated to 2 groups using computer-generated randomization method. Neither participants nor physicians will be blinded to the groups because of organizational reasons

Intervention model description

Arm 1: standard nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 1\. patients who will undergo endoscopic retrograde cholangiopancreatography under conscious sedation

Exclusion criteria

* 1\. dementia or cognitive dysfunction * 2\. altered mental status * 3\. intubated patients or tracheostomy * 4\. pregnancy * 5\. recent history of nasal bleeding * 6\. illiteracy or foreigner

Design outcomes

Primary

Measure	Time frame	Description
lowest SpO2 measured with pulse oximetry during the procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)	The investigators will record the lowest SpO2 during the procedure.

Secondary

Measure	Time frame	Description
incidence of desaturation below 90% during the procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography)	The investigators will compare the incidence of desaturation during the procedure between the two groups.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026