Deep SedationNCT07630038
HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy
A study testing High-Flow Nasal Oxygen 40 L/min (HF40), High-Flow Nasal Oxygen 55 L/min (HF55) and High-Flow Nasal Oxygen 70 L/min (HF70) in people with Deep Sedation and High Flow Nasal Canula, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
For Patients and Families This study aims to investigate how high-flow oxygen therapy affects oxygen levels, especially brain oxygenation, during cystoscopy procedures performed under sedation. The goal is to improve patient safety and comfort by ensuring better oxygen delivery during the procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Sedation, High Flow Nasal Canula, Cerebral Oxygenation
- What is being tested?
- High-Flow Nasal Oxygen 40 L/min (HF40), High-Flow Nasal Oxygen 55 L/min (HF55) and High-Flow Nasal Oxygen 70 L/min (HF70)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Scheduled to undergo elective cystoscopy under procedural sedation in an operating room setting
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Ability to provide written informed consent
Who cannot join
- Known neurological disorders
- History of ischemic or hemorrhagic stroke
- Peripheral artery disease
- Vasculitis
- Severe heart failure
- Uncontrolled hypertension
Show all 13Show fewer
- Uncontrolled diabetes mellitus
- Advanced-stage chronic obstructive pulmonary disease
- Severe anemia (hemoglobin <8 g/dL)
- Skin lesions that could interfere with near-infrared spectroscopy (NIRS) measurements
- History of head trauma
- History of cranial surgery
- Nasal deformity or nasal obstruction
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
Fırat University Faculty of Medicine Hospital
Elâzığ, Elaziğ, 23100
Ahmet Aksu, Assistant Professor, 05303493896, drahmetaksu@gmail.com
About this study
Official title: Effect of Different Flow Rates of High-Flow Nasal Oxygen on Peripheral and Cerebral Oxygenation and Ventilation During Procedural Sedation for Cystoscopy: A Prospective Randomized Controlled Trial
For Patients and Families
This study aims to investigate how high-flow oxygen therapy affects oxygen levels, especially brain oxygenation, during cystoscopy procedures performed under sedation. The goal is to improve patient safety and comfort by ensuring better oxygen delivery during the procedure. Different oxygen flow rates will be compared, while patients' breathing, oxygen levels, and vital signs are continuously monitored throughout the procedure. All methods used in the study are consistent with routine anesthesia practices, and patient safety remains the highest priority.
Read more
For Healthcare Professionals
This prospective randomized controlled study evaluates the effects of different high-flow nasal oxygen (HFNO) flow rates on cerebral oxygenation, peripheral oxygenation, and ventilation parameters in patients undergoing cystoscopy under procedural sedation. The primary aim is to determine the contribution of HFNO to sedation safety and to provide clinical evidence regarding the optimal flow rate. In addition, hypoxemia incidence, airway intervention requirements, hemodynamic variables, and sedation depth are being analyzed.
- Conditions
- Deep Sedation, High Flow Nasal Canula, Cerebral Oxygenation, PSI
- Being tested
- High-Flow Nasal Oxygen 40 L/min (HF40), High-Flow Nasal Oxygen 55 L/min (HF55), High-Flow Nasal Oxygen 70 L/min (HF70)
- Keywords
- High Flow Nasal Canula, Deep Sedation, rSO2, PSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen 40 L/min (HF40)Device
Participants receive high-flow nasal oxygen (HFNO) therapy delivered through the OptiFlow™ system at a flow rate of 40 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy. Sedation is achieved using midazolam, remifentanil, and propofol.
High-Flow Nasal Oxygen 55 L/min (HF55)Device
Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 55 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol.
High-Flow Nasal Oxygen 70 L/min (HF70)Device
Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 70 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol.
| Study group | Role | What they receive |
|---|---|---|
| HF40 | Experimental | Participants receive high-flow nasal oxygen (HFNO) therapy at a flow rate of 40 L/min during procedural sedation for cystoscopy. Receives: Device: High-Flow Nasal Oxygen 40 L/min (HF40) |
| HF55 | Experimental | Participants receive HFNO therapy at a flow rate of 55 L/min during procedural sedation for cystoscopy. Receives: Device: High-Flow Nasal Oxygen 55 L/min (HF55) |
| HF70 | Experimental | Participants receive HFNO therapy at a flow rate of 70 L/min during procedural sedation for cystoscopy. Receives: Device: High-Flow Nasal Oxygen 70 L/min (HF70) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Regional Cerebral Oxygen Saturation (rSO₂)
Unit: %. Regional cerebral oxygen saturation values measured by near-infrared spectroscopy (NIRS) during procedural sedation will be compared among the three HFNO flow rate groups to evaluate the effect of different HFNO flow rates on cerebral oxygenation.
Measured: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Secondary outcomes (10)
Peripheral Oxygen Saturation (SpO₂)
Unit: % . Evaluation of peripheral oxygenation levels during procedural sedation.
Measured: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Partial arterial carbon dioxide pressure (PaCO₂)
Unit: mmHg. Assessment of arterial carbon dioxide pressure levels during sedation.
Measured: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. Arterial blood gas analysis (PaCO₂) and end-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
End-tidal carbon dioxide (EtCO₂)
Unit: mmHg. Assessment of end-tidal carbon dioxide levels during sedation.
Measured: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. End-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
Incidence of Hypoxemia
Frequency of hypoxemia episodes defined as SpO₂ <90% or >20% decrease in rSO₂ from baseline.
Measured: From the initiation of procedural sedation until the end of the cystoscopy procedure. Hypoxemia episodes occurring during the intraoperative sedation period will be recorded continuously.
Airway Intervention Requirement
Need for airway maneuvers or ventilatory support during the procedure.
Measured: From the initiation of procedural sedation until the end of the cystoscopy procedure. Any airway intervention requirement occurring during the intraoperative period will be recorded.
Heart Rate
Unit: beats/min. Changes in heart rate during procedural sedation.
Measured: From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
Mean Arterial Pressure
Unit: mmHg. Changes in blood pressure during procedural sedation.
Measured: From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
Patient State Index (PSI)
Unit of Measure: score. Sedation depth will be continuously monitored intraoperatively using Patient State Index (PSI), a numerical electroencephalography-derived index ranging from 0 to 100, where lower values indicate deeper levels of sedation.
Measured: From the initiation of sedation until the end of the cystoscopy procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Unit of Measure: score. Sedation depth will be assessed intraoperatively using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale, an ordinal sedation scale ranging from 0 to 5, where lower scores indicate deeper levels of sedation.
Measured: From the initiation of sedation until the end of the cystoscopy procedure.
Patient Satisfaction
Postoperative patient satisfaction following cystoscopy under procedural sedation will be assessed using a 5-point Likert satisfaction scale, where higher scores indicate greater patient satisfaction.
Measured: Assessed once at the end of the recovery period immediately after completion of the cystoscopy procedure (postoperative period, approximately 30-60 minutes after the procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, parallel-group controlled study designed to evaluate the effects of different high-flow nasal oxygen (HFNO) flow rates during deep procedural sedation for cystoscopy. Participants are randomly assigned to one of three groups receiving HFNO at 40, 55, or 70 L/min. The study compares cerebral oxygenation, peripheral oxygenation, ventilation parameters, hypoxemia incidence, airway intervention requirements, and hemodynamic variables among the groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 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
- NCT07630038
- Sponsor's protocol ID
- 47669
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to patient confidentiality, privacy concerns, and institutional ethical regulations. Data may be made available from the corresponding author upon reasonable request and with ethics committee approval
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Flow Rates of High-Flow Nasal Oxygen on Peripheral and Cerebral Oxygenation and Ventilation During Procedural Sedation for Cystoscopy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07630038
- Acronym / sponsor ID
- 47669
- Conditions
- Deep Sedation, High Flow Nasal Canula, Cerebral Oxygenation, PSI
- Keywords
- High Flow Nasal Canula, Deep Sedation, rSO2, PSI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Jun 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.
For Patients and Families
This study aims to investigate how high-flow oxygen therapy affects oxygen levels, especially brain oxygenation, during cystoscopy procedures performed under sedation. The goal is to improve patient safety and comfort by ensuring better oxygen delivery during the procedure. Different oxygen flow rates will be compared, while patients' breathing, oxygen levels, and vital signs are continuously monitored throughout the procedure. All methods used in the study are consistent with routine anesthesia practices, and patient safety remains the highest priority.
For Healthcare Professionals
This prospective randomized controlled study evaluates the effects of different high-flow nasal oxygen (HFNO) flow rates on cerebral oxygenation, peripheral oxygenation, and ventilation parameters in patients undergoing cystoscopy under procedural sedation. The primary aim is to determine the contribution of HFNO to sedation safety and to provide clinical evidence regarding the optimal flow rate. In addition, hypoxemia incidence, airway intervention requirements, hemodynamic variables, and sedation depth are being analyzed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a prospective, randomized, parallel-group controlled study designed to evaluate the effects of different high-flow nasal oxygen (HFNO) flow rates during deep procedural sedation for cystoscopy. Participants are randomly assigned to one of three groups receiving HFNO at 40, 55, or 70 L/min. The study compares cerebral oxygenation, peripheral oxygenation, ventilation parameters, hypoxemia incidence, airway intervention requirements, and hemodynamic variables among the groups.
| Arm | Type | Receives |
|---|---|---|
| HF40 | Experimental | Device: High-Flow Nasal Oxygen 40 L/min (HF40)Participants receive high-flow nasal oxygen (HFNO) therapy at a flow rate of 40 L/min during procedural sedation for cystoscopy. |
| HF55 | Experimental | Device: High-Flow Nasal Oxygen 55 L/min (HF55)Participants receive HFNO therapy at a flow rate of 55 L/min during procedural sedation for cystoscopy. |
| HF70 | Experimental | Device: High-Flow Nasal Oxygen 70 L/min (HF70)Participants receive HFNO therapy at a flow rate of 70 L/min during procedural sedation for cystoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Scheduled to undergo elective cystoscopy under procedural sedation in an operating room setting
- American Society of Anesthesiologists (ASA) physical status classification I-III
- Ability to provide written informed consent
Key exclusion criteria (13 listed)
- Known neurological disorders
- History of ischemic or hemorrhagic stroke
- Peripheral artery disease
- Vasculitis
- Severe heart failure
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 40 L/min (HF40)Participants receive high-flow nasal oxygen (HFNO) therapy delivered through the OptiFlow™ system at a flow rate of 40 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy. Sedation is achieved using midazolam, remifentanil, and propofol. | Device | HF40 |
| High-Flow Nasal Oxygen 55 L/min (HF55)Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 55 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol. | Device | HF55 |
| High-Flow Nasal Oxygen 70 L/min (HF70)Participants receive HFNO therapy via the OptiFlow™ system at a flow rate of 70 L/min with 100% heated and humidified oxygen during procedural sedation for cystoscopy, together with the same standardized sedation protocol. | Device | HF70 |
Primary outcome
Change in Regional Cerebral Oxygen Saturation (rSO₂)
Time frame: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Unit: %. Regional cerebral oxygen saturation values measured by near-infrared spectroscopy (NIRS) during procedural sedation will be compared among the three HFNO flow rate groups to evaluate the effect of different HFNO flow rates on cerebral oxygenation.
10 secondary outcomes
Peripheral Oxygen Saturation (SpO₂)
Time frame: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.
Partial arterial carbon dioxide pressure (PaCO₂)
Time frame: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. Arterial blood gas analysis (PaCO₂) and end-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
End-tidal carbon dioxide (EtCO₂)
Time frame: At baseline before the initiation of sedation and at the end of the cystoscopy procedure. End-tidal carbon dioxide (EtCO₂) measurements will be recorded at both time points.
Incidence of Hypoxemia
Time frame: From the initiation of procedural sedation until the end of the cystoscopy procedure. Hypoxemia episodes occurring during the intraoperative sedation period will be recorded continuously.
Airway Intervention Requirement
Time frame: From the initiation of procedural sedation until the end of the cystoscopy procedure. Any airway intervention requirement occurring during the intraoperative period will be recorded.
Heart Rate
Time frame: From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period.
Mean Arterial Pressure
Time frame: From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period.
Patient State Index (PSI)
Time frame: From the initiation of sedation until the end of the cystoscopy procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
Time frame: From the initiation of sedation until the end of the cystoscopy procedure.
Patient Satisfaction
Time frame: Assessed once at the end of the recovery period immediately after completion of the cystoscopy procedure (postoperative period, approximately 30-60 minutes after 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 5 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to patient confidentiality, privacy concerns, and institutional ethical regulations. Data may be made available from the corresponding author upon reasonable request and with ethics committee approval
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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 40 L/min (HF40), High-Flow Nasal Oxygen 55 L/min (HF55) and High-Flow Nasal Oxygen 70 L/min (HF70) in people with Deep Sedation and High Flow Nasal Canula, 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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 5 Jun 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 (rSO₂) (time frame: From baseline measurement before sedation until the end of the cystoscopy procedure (intraoperative period). Cerebral oxygen saturation (rSO₂) values are recorded continuously during procedural sedation.). 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 5 Jun 2026.