HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation

NCT07718295 | Recruiting

• 1 other identifier: 47670
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled trial aims to compare the effects of high-flow nasal oxygen (HFNO) and conventional face mask oxygen therapy on cerebral oxygenation during procedural sedation performed outside the operating room. Adult patients undergoing elective diagnostic or interventional procedures under procedural sedation will be randomly assigned to receive either HFNO or conventional face mask oxygen. Regional cerebral oxygen saturation will be continuously monitored using near-infrared spectroscopy (NIRS), while sedation depth will be assessed using the Patient State Index (PSI, SedLine) and the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Secondary outcomes include peripheral oxygenation, ventilation parameters, arterial blood gas values, airway interventions, hemodynamic variables, and patient and practitioner satisfaction.

Conditions

Procedural Sedation; Hypoxemia; Cerebral Oxygenation; SEDLine

Keywords

High-flow nasal oxygen (HFNO); Procedural sedation; Cerebral oxygenation; Near-infrared spectroscopy (NIRS); Patient State Index (PSI)

Outcome Measures

Primary Outcomes (1)

• Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)

  The change in regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS), calculated as the difference between the mean intra-procedural rSO₂ and the baseline value.

  From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).

Secondary Outcomes (14)

• Peripheral Oxygen Saturation (SpO₂)

  From baseline to completion of procedural sedation (up to approximately 120 minutes).

• End-Tidal Carbon Dioxide (EtCO₂)

  Baseline and at completion of the procedure.

• Arterial Oxygen Tension (PaO₂)

  Before sedation and immediately after completion of the procedure.

• Arterial Carbon Dioxide Tension (PaCO₂)

  Before sedation and immediately after completion of the procedure.

• Incidence of Hypoxemia

  During procedural sedation (up to approximately 120 minutes).

Study Arms (2)

High-Flow Nasal Oxygen (HFNO)

EXPERIMENTAL

Participants receive heated humidified high-flow nasal oxygen during procedural sedation.

Device: High-Flow Nasal Oxygen (HFNO)

Conventional Face Mask Oxygen

ACTIVE COMPARATOR

Participants receive conventional face mask oxygen therapy during procedural sedation.

Device: Conventional Face Mask Oxygen

Interventions

High-Flow Nasal Oxygen (HFNO) DEVICE

Participants receive heated humidified high-flow nasal oxygen during procedural sedation.

High-Flow Nasal Oxygen (HFNO)

Conventional Face Mask Oxygen DEVICE

Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.

Conventional Face Mask Oxygen

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• American Society of Anesthesiologists physical status I-IV
• Scheduled for an elective diagnostic or interventional procedure performed under procedural sedation in a non-operating-room setting
• Ability to provide written informed consent
• Willingness to participate in the study

You may not qualify if:

• Age younger than 18 years
• Refusal or inability to provide written informed consent
• Known neurological disorders
• History of ischemic or hemorrhagic stroke
• History of traumatic brain injury or previous cranial surgery
• Peripheral arterial disease or systemic vasculitis
• Advanced heart failure
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Advanced chronic obstructive pulmonary disease (COPD)
• Severe anemia (hemoglobin \<8 g/dL)
• Skin lesions or other conditions preventing proper placement of NIRS sensors
• Nasal deformity or nasal obstruction preventing the use of high-flow nasal oxygen therapy
• Any condition that, in the opinion of the investigators, could interfere with study participation or the interpretation of study results

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat University Faculty of Medicine Hospital

Elâzığ, Elâzığ, 23100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ahmet Aksu, Assistant Professor

CONTACT

+905303493896; drahmetaksu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either high-flow nasal oxygen (HFNO) or conventional face mask oxygen therapy during procedural sedation performed outside the operating room. Both groups will undergo the same standardized sedation protocol, monitoring, and perioperative management, differing only in the oxygen delivery method. Outcomes will be compared between the two parallel groups.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 21, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)