Procedural SedationNCT07718295
HFNO Versus Face Mask for Cerebral Oxygenation During Procedural Sedation
A study testing High-Flow Nasal Oxygen (HFNO) and Conventional Face Mask Oxygen in people with Procedural Sedation and Hypoxemia, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation, Hypoxemia, Cerebral Oxygenation
- What is being tested?
- High-Flow Nasal Oxygen (HFNO) and Conventional Face Mask Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Fırat University Faculty of Medicine Hospital
Elâzığ, Elâzığ, 23100
Ahmet Aksu, Assistant Professor, +905303493896 ext. +904242333555, drahmetaksu@gmail.com
Ahmet Demirdağ, Assistant Professor, +905427158774, a.demirdag@firat.edu.tr
About this study
Official title: Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial
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
- Being tested
- High-Flow Nasal Oxygen (HFNO), Conventional Face Mask Oxygen
- Keywords
- High-flow nasal oxygen (HFNO), Procedural sedation, Cerebral oxygenation, Near-infrared spectroscopy (NIRS), Patient State Index (PSI)
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen (HFNO)Device
Participants receive heated humidified high-flow nasal oxygen during procedural sedation.
Conventional Face Mask OxygenDevice
Oxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%.
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Nasal Oxygen (HFNO) | Experimental | Participants receive heated humidified high-flow nasal oxygen during procedural sedation. Receives: Device: High-Flow Nasal Oxygen (HFNO) |
| Conventional Face Mask Oxygen | Active comparator | Participants receive conventional face mask oxygen therapy during procedural sedation. Receives: Device: Conventional Face Mask Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).
Secondary outcomes (14)
Peripheral Oxygen Saturation (SpO₂)
Measured: From baseline to completion of procedural sedation (up to approximately 120 minutes).
End-Tidal Carbon Dioxide (EtCO₂)
Measured: Baseline and at completion of the procedure.
Arterial Oxygen Tension (PaO₂)
Measured: Before sedation and immediately after completion of the procedure.
Arterial Carbon Dioxide Tension (PaCO₂)
Measured: Before sedation and immediately after completion of the procedure.
Incidence of Hypoxemia
Peripheral oxygen saturation <90% lasting at least 10 seconds.
Measured: During procedural sedation (up to approximately 120 minutes).
Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline
Number of participants who experience a decrease in regional cerebral oxygen saturation (rSO₂) of 20% or more from the baseline value during procedural sedation.
Measured: During procedural sedation (up to approximately 120 minutes).
Number of Participants Requiring Airway Intervention During Procedural Sedation
Number of participants requiring any airway intervention, including chin lift, jaw thrust, mask ventilation, supraglottic airway placement, or endotracheal intubation during procedural sedation.
Measured: During procedural sedation.
Patient State Index (PSI) During Procedural Sedation
Mean Patient State Index (PSI) recorded throughout procedural sedation. The PSI ranges from 0 to 100, with lower values indicating deeper levels of sedation.
Measured: Throughout procedural sedation until completion of the procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation
Mean Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score recorded during procedural sedation. Scores range from 0 to 5, where lower scores indicate deeper sedation and higher scores indicate greater alertness.
Measured: Throughout procedural sedation until completion of the procedure.
Heart Rate During Procedural Sedation
Mean heart rate (beats per minute) recorded from baseline until completion of the procedure.
Measured: From baseline until completion of the procedure.
Mean Arterial Pressure During Procedural Sedation
Mean non-invasive arterial blood pressure (mmHg) recorded from baseline until completion of the procedure.
Measured: Throughout procedural sedation until completion of the procedure.
Sedative Drug Consumption
Total doses of propofol, remifentanil, and midazolam.
Measured: During procedural sedation.
Patient Satisfaction Score Using a 5-Point Likert Scale
Patient satisfaction was assessed immediately after recovery using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Measured: Immediately after recovery from procedural sedation.
Practitioner Satisfaction Score Using a 5-Point Likert Scale
Practitioner satisfaction with the procedure was assessed immediately after completion using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.
Measured: Immediately after completion of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMET AKSU, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718295
- Sponsor's protocol ID
- 47670
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan, and participant-level data contain potentially identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-Flow Nasal Oxygen Versus Conventional Face Mask Oxygen on Cerebral Oxygenation During Out-of-Operating-Room Procedural Sedation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07718295
- Acronym / sponsor ID
- 47670
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High-Flow Nasal Oxygen (HFNO) | Experimental | Device: High-Flow Nasal Oxygen (HFNO)Participants receive heated humidified high-flow nasal oxygen during procedural sedation. |
| Conventional Face Mask Oxygen | Active comparator | Device: Conventional Face Mask OxygenParticipants receive conventional face mask oxygen therapy during procedural sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Flow Nasal Oxygen (HFNO)Participants receive heated humidified high-flow nasal oxygen during procedural sedation. | Device | High-Flow Nasal Oxygen (HFNO) |
| Conventional Face Mask OxygenOxygen administered through a conventional face mask at 6 L/min with an approximate FiO₂ of 40%. | Device | Conventional Face Mask Oxygen |
Primary outcome
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂)
Time frame: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).
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.
14 secondary outcomes
Peripheral Oxygen Saturation (SpO₂)
Time frame: From baseline to completion of procedural sedation (up to approximately 120 minutes).
End-Tidal Carbon Dioxide (EtCO₂)
Time frame: Baseline and at completion of the procedure.
Arterial Oxygen Tension (PaO₂)
Time frame: Before sedation and immediately after completion of the procedure.
Arterial Carbon Dioxide Tension (PaCO₂)
Time frame: Before sedation and immediately after completion of the procedure.
Incidence of Hypoxemia
Time frame: During procedural sedation (up to approximately 120 minutes).
Number of Participants with a ≥20% Decrease in Regional Cerebral Oxygen Saturation (rSO₂) from Baseline
Time frame: During procedural sedation (up to approximately 120 minutes).
Number of Participants Requiring Airway Intervention During Procedural Sedation
Time frame: During procedural sedation.
Patient State Index (PSI) During Procedural Sedation
Time frame: Throughout procedural sedation until completion of the procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score During Procedural Sedation
Time frame: Throughout procedural sedation until completion of the procedure.
Heart Rate During Procedural Sedation
Time frame: From baseline until completion of the procedure.
Mean Arterial Pressure During Procedural Sedation
Time frame: Throughout procedural sedation until completion of the procedure.
Sedative Drug Consumption
Time frame: During procedural sedation.
Patient Satisfaction Score Using a 5-Point Likert Scale
Time frame: Immediately after recovery from procedural sedation.
Practitioner Satisfaction Score Using a 5-Point Likert Scale
Time frame: Immediately after completion of the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study was not designed with a data-sharing plan, and participant-level data contain potentially identifiable information.
Related trials for Procedural Sedation
Not yet recruitingPhase 4
Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.
Procedural Sedation
RecruitingObservational study
PRedictors Of Maladaptive Behaviors in Children Undergoing Procedural SEDation
Procedural Sedation and Analgesia
Recruiting
Anesthesia Management in Endovascular Therapy for Ischemic Stroke - 2
Ischemic Stroke, Anterior Cerebral Circulation
Active, not recruitingObservational study
Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window
Pericardial Effusion, Inflammatory Response After Surgery
RecruitingObservational study
Consent Understanding and Propofol Requirement During Endobronchial Ultrasound
ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION, Procedural Sedation and Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Nasal Oxygen (HFNO) and Conventional Face Mask Oxygen in people with Procedural Sedation and Hypoxemia, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Aksu, Assistant Professor (+905303493896, drahmetaksu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Regional Cerebral Oxygen Saturation (ΔrSO₂) (time frame: From initiation of procedural sedation until completion of the procedure (up to approximately 120 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.