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Completed

NCT Number: NCT03872674

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

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.

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Key information

Conditions

Patients Undergoing Endoscopic Retrograde Cholangiopancreatography in Prone Position

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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.

Primary outcomes

  1. lowest SpO2 measured with pulse oximetry during the procedure

    Time frame: 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 outcomes

  1. incidence of desaturation below 90% during the procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2019
Registry last updated
May 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.