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

Yonsei University

Status: Not yet enrolling

Conditions: Patients Undergoing Endoscopic Submucosal Dissection

Treatments: Device: high-flow humidified oxygen-delivery system (OptiFlow THRIVE); Device: conventional oxygenation (nasal cannula)

Study type: Interventional

Funder types: Other

Identifiers

NCT06688019

4-2024-1108

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

conventional oxygenation (nasal cannula) arm

Experimental group

Description:

conventional oxygenation arm will receive oxygen at 2L/min via nasal cannula

Treatment:

Device: conventional oxygenation (nasal cannula)

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

Experimental group

Description:

Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE

Treatment:

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