A study on the effectiveness of maintaining oxygenation of a new high flow nasal cannula for endoscopic retrograde cholangiopancreatography during intravenous anesthesia.

JRCT ID: jRCTs072240096

Registered date:16/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Health status that allows for inpatient ERCP under sedation
• Date of first enrollment: 16/01/2025
• Target sample size: 144
• Study type: Interventional
• Intervention(s): High flow nasal cannula

Outcome(s)

• Primary Outcome: Incidence of hypoxemia

Secondary Outcome

i) Percentage of significant hyperCO2emia during venous anesthesia (transcutaneous CO2 concentration > 60 mmHg)
ii) Percentage of moderate hyperCO2emia during venous anesthesia (transcutaneous CO2 concentration > 50 mmHg)
iii) Area under the curve (AUC) of transcutaneous CO2 concentration per unit time during venous anesthesia
iv)) Mean respiratory rate during venous anesthesia
v) Total dose of sedative drug and dose per anesthesia hour
vi) Total dose of sedative drug, dose per anesthesia hour
vii) Ramsay scale score
viii) Incidence of severe hypoxemia
ix) Incidence of sustained hypoxemia
(Definition of sustained hypoxemia: hypoxemia lasting more than 10 seconds)
10) ERCP bile duct intubation time, total procedure time

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

i) Patients scheduled for inpatient endoscopic retrograde cholangiopancreatography (ERCP) under sedation
ii) Age: Patients who are at least 18 years old and less than 85 years old.
iii) Patients who have been fully informed about their participation in this study and who have given written consent of their own free will based on their full understanding of the study.

Exclude criteria

i) Patients receiving continuous oxygen administration by nasal cannula (home oxygen therapy)
ii) Patients with a history of pneumothorax
iii) Patients with a history of bronchial asthma attack or severe asthma
iv) Patients participating in clinical trials or other clinical studies
v) Other patients who are deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Takahashi Kosuke
• Source(s) of Monetary Support: Fisher &amp; Paykel Healthcare