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HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy

ConditionsDeep SedationHigh Flow Nasal CanulaCerebral OxygenationPSI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirat University

About this 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.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Known neurological disorders

History of ischemic or hemorrhagic stroke

Peripheral artery disease

Vasculitis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: HF40Experimental treatment 1 intervention
Group B: HF55Experimental treatment 1 intervention
Group C: HF70Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Secondary outcomes

1

Peripheral Oxygen Saturation (SpO₂)

Unit: % . Evaluation of peripheral oxygenation levels during procedural sedation.

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.
2

Partial arterial carbon dioxide pressure (PaCO₂)

Unit: mmHg. Assessment of arterial carbon dioxide pressure levels during sedation.

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.
3

End-tidal carbon dioxide (EtCO₂)

Unit: mmHg. Assessment of end-tidal carbon dioxide levels during sedation.

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.
4

Incidence of Hypoxemia

Frequency of hypoxemia episodes defined as SpO₂ \<90% or \>20% decrease in rSO₂ from baseline.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Firat University

Lead sponsor

Source ClinicalTrials.gov

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