A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conventional oxygenation (nasal cannula), high-flow humidified oxygen-delivery system (OptiFlow THRIVE).
- Who it may be relevant to
- Registry conditions: Patients Undergoing Endoscopic Submucosal Dissection. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Interventions
- Device conventional oxygenation (nasal cannula)
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. - Device high-flow humidified oxygen-delivery system (OptiFlow THRIVE)
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 outcome measures
- 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]
Secondary outcome measures (4)
- the number and duration of hypoxemia [Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour]
- the lowest SpO2 during procedure [Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour]
- need for airway intervention [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 [Time frame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06688019 · 4-2024-1108