Patients Undergoing Endoscopic Submucosal Dissection
Conditions
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.
Interventions
DEVICEconventional 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.
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Patients will be randomly allocated to 2 groups using computer-generated randomization method. Neither participants nor physicians will be blinded to the groups because of organizational reasons.
Intervention model description
Arm 1: conventional nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactNamo Kim
Outcome results
None listed