Not Yet Recruiting

NCT Number: NCT06688019

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Patients Undergoing Endoscopic Submucosal Dissection

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 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 outcomes

the number and duration of hypoxemia

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Namo Kim

CONTACT

[email protected]

82-2-2224-3200

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 14, 2024
Registry last updated: Nov 14, 2024

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.