NCT07500779

Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy: A Brain Function Monitoring (SedLine)-Guided Randomized Controlled Trial (NAMSHIC)

Comparison of the Efficacy of Nasal Mask and Nasal Cannula Oxygenation During Gastrointestinal Endoscopic Procedures Performed Under Target-Controlled Propofol Infusion Anesthesia With Brain Function Monitoring (SedLine): A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial compared the efficacy of a nasal mask versus a standard nasal cannula for oxygen delivery during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. Hypoxemia during procedural sedation is a common and clinically relevant event, especially during upper endoscopy and combined procedures. The study aimed to determine whether nasal mask oxygenation reduces hypoxemia compared with nasal cannula oxygenation when sedation depth is guided with electroencephalography based monitoring. Eligible adult patients undergoing gastrointestinal endoscopic procedures were randomly assigned to receive oxygen either via a nasal mask or via a nasal cannula. Oxygen was administered at a fixed flow rate according to the study protocol. Sedation was provided with target controlled propofol infusion, and SedLine monitoring was used to guide sedation depth throughout the procedure. The primary outcome was the occurrence of hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, lowest peripheral oxygen saturation value, need for airway interventions, other adverse events during the procedure, procedure time, recovery time, and operator satisfaction ratings. The study has been completed.

Detailed description

This study was a prospective randomized controlled trial designed to compare two oxygen delivery approaches during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. The main objective was to evaluate whether nasal mask oxygenation provides better protection against hypoxemia than standard nasal cannula oxygenation when sedation depth is actively guided with electroencephalography based monitoring. Adult patients scheduled for gastrointestinal endoscopic procedures were assessed for eligibility and enrolled after appropriate ethical approval and informed consent procedures in accordance with local regulations. Participants were randomly assigned to one of two groups. In the nasal mask group, oxygen was delivered using a nasal mask device. In the nasal cannula group, oxygen was delivered using a standard nasal cannula. Oxygen flow was administered as specified in the protocol. Sedation for all patients was provided with target controlled propofol infusion. SedLine brain function monitoring was used to guide and standardize sedation depth during the procedure to reduce variability related to over sedation or under sedation. The primary outcome was hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, the minimum peripheral oxygen saturation recorded, need for airway support or rescue interventions, procedure related adverse events such as cough, hiccup, nausea, vomiting, reflux, aspiration, and laryngospasm, total procedure time, recovery time, and satisfaction ratings by the anesthesiologist and the endoscopist. All outcomes were assessed during the procedure and the immediate recovery period based on standardized definitions in the study protocol. The study has been completed, and the collected data are intended to support evaluation of the comparative effectiveness and safety of nasal mask versus nasal cannula oxygenation in this clinical setting.

Conditions

• Hypoxemia
• Conscious Sedation

Interventions

Type	Name	Description
DEVICE	Nasal Mask Oxygenation	Oxygen supplementation delivered via a nasal mask at the protocol specified flow rate during the procedure.
DEVICE	Nasal Cannula Oxygenation	Oxygen supplementation delivered via a standard nasal cannula at the protocol specified flow rate during the procedure.

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-08-26
• Completion: 2025-11-15
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Turkey (Türkiye)