Study on prevention of hypercapnia by Nasal High Flow in patients undergoing endoscopic retrograde cholangiopancreatography during intravenous anesthesia

JRCT ID: jRCTs072190021

Registered date:26/08/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Biliary disease
• Date of first enrollment: 14/01/2020
• Target sample size: 80
• Study type: Interventional
• Intervention(s): NHF intervention

Outcome(s)

Primary Outcome

1) Occurrence of marked hypercarbonemia showing maximum value of percutaneous carbon dioxide concentration over 60 mmHg (equivalent to PaCO2> 55 mmHg) during intravenous anesthesia
2) Area under curve (AUC) of percutaneous carbon dioxide concentration per unit time at intravenous anesthesia
3) Duration of moderate hypercarbonemia showing maximum value of 50mmHg or more (equivalent to PaCO2> 45mmHg) during percutaneous anesthesia with intravenous anesthesia
4) Occurrence of hypoxemia showing 90% or less of the value of percutaneous oxygen saturation during intravenous anesthesia

Secondary Outcome

1) Anesthesia depth assessment (Ramsay scale)
2) Anesthesia dose

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1) Age: Adult patients whose age is between 20 and 85 years old at the time of obtaining consent
2) Gender: Any question
3) Hospitalization / outpatient: hospitalization only
4) Patients who have received sufficient explanation for participation in this study, and who have received sufficient written consent from the patient himself / herself with sufficient understanding.

Exclude criteria

1) Continuous administration of oxygen by nasal cannula (home oxygen therapy)
2) Patients who cannot breathe nose
3) Patients who cannot reduce or discontinue antithrombotic drugs on the day before the endoscope
4) Patients with a history of pneumothorax
5) Other patients who are determined to be inappropriate as research subjects by the principal investigator
6) Patients who are positive for the new coronavirus (SARS-CoV-2) PCR test

Related Information

• Primary Sponsor: Ayuse Takao
• Source(s) of Monetary Support: Fisher &amp; Paykel Healthcare Limited