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

NCT07500779 | Completed

• 1 other identifier: 2024/392
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemia; Conscious Sedation

Keywords

Gastrointestinal Endoscopy; Propofol; Target-Controlled Infusion; SedLine; Nasal Mask; Nasal Cannula; Oxygenation; Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• Hypoxemia

  Occurrence of hypoxemia defined as peripheral oxygen saturation (SpO2) ≤ 90% during the procedure

  During the endoscopic procedure and immediate recovery period (from start of sedation to discharge from the recovery area).

Secondary Outcomes (8)

• Severe hypoxemia

  During the endoscopic procedure and immediate recovery period

• Duration of hypoxemia

  During the endoscopic procedure and immediate recovery period.

• Minimum SpO2

  During the endoscopic procedure

• Need for airway interventions

  During the endoscopic procedure and immediate recovery period

• Procedure-related adverse events

  During the endoscopic procedure and immediate recovery period.

Study Arms (2)

Nasal Mask Oxygenation

EXPERIMENTAL

Oxygen was delivered via a nasal mask during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring.

Device: Nasal Mask Oxygenation

Nasal Cannula Oxygenation

ACTIVE COMPARATOR

Oxygen was delivered via a standard nasal cannula during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine brain function monitoring.

Device: Nasal Cannula Oxygenation

Interventions

Nasal Mask Oxygenation DEVICE

Oxygen supplementation delivered via a nasal mask at the protocol specified flow rate during the procedure.

Nasal Mask Oxygenation

Nasal Cannula Oxygenation DEVICE

Oxygen supplementation delivered via a standard nasal cannula at the protocol specified flow rate during the procedure.

Nasal Cannula Oxygenation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Scheduled for gastrointestinal endoscopic procedures (upper endoscopy and or colonoscopy) under propofol sedation using target controlled infusion with SedLine monitoring.
• American Society of Anesthesiologists (ASA) physical status I to III.
• Provided written informed consent.

You may not qualify if:

• Refusal or inability to provide informed consent.
• Known allergy or contraindication to propofol or study related materials.
• Severe cardiorespiratory instability or conditions judged by the investigator to increase procedural risk.
• Pregnancy.
• Requirement for tracheal intubation or general anesthesia at the outset of the procedure.
• Significant anatomic or clinical factors precluding use of the assigned oxygen delivery device.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label due to the visible nature of the oxygen delivery device. Outcome measures were based on objective pulse oximetry and standardized definitions.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomized controlled trial comparing nasal mask versus nasal cannula oxygenation during gastrointestinal endoscopic procedures performed under target controlled propofol infusion with SedLine monitoring.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: March 30, 2026
• Study Start: January 6, 2025
• Primary Completion: August 26, 2025
• Study Completion: November 15, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

TU (1)