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

N/ANot Yet RecruitingNCT06688019

Yonsei University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

200

Conditions

Patients Undergoing Endoscopic Submucosal Dissection

Interventions

conventional oxygenation (nasal cannula)DEVICE

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

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

conventional oxygenation arm will receive oxygen at 2 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure

We will record the incidence of hypoxemia during the procedure.

Time frame: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour

Secondary Outcomes

the number and duration of hypoxemia

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.

Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour

the lowest SpO2 during procedure

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.

Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour

need for airway intervention

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.

Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour

the end tidal CO2 at the end of the procedure

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.

Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour

Central Contacts

Namo Kim

CONTACT

82-2-2224-3200 namo@yuhs.ac

Data from ClinicalTrials.gov

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