A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection

Not Applicable

Not yet recruiting

• Conditions: Patients Undergoing Endoscopic Submucosal Dissection

• Registration Number: NCT06688019
• Lead Sponsor: Yonsei University

Brief Summary

Sedation for endoscopic submucosal dissection 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 submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14
• Primary Completion: 2025-10-18
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation

Exclusion Criteria

• dementia or cognitive dysfunction
• altered mental status
• intubated patients or tracheostomy
• pregnancy
• recent history of nasal bleeding
• contraindication for positive pressure ventilation
• patients under oxygen therapy
• illiteracy or foreigner

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure	during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour	We will record the incidence of hypoxemia during the procedure.

Secondary Outcome Measures

Name	Time	Method
the number and duration of hypoxemia	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour	We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
the lowest SpO2 during procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour	We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
need for airway intervention	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour	We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.
the end tidal CO2 at the end of the procedure	during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour	We will compare the number and duration of hypoxemia, the lowest SpO2 during procedure, need for airway intervention, the end tidal CO2 at the end of the procedure between the two groups.