HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy

N/ANot Yet RecruitingNCT07630038

Firat University200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Enrollment

200

Conditions

Deep Sedation High Flow Nasal Canula

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Known neurological disorders * History of ischemic or hemorrhagic stroke * Peripheral artery disease * Vasculitis * Severe heart failure * Uncontrolled hypertension * 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

Outcomes

Primary Outcomes

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

Peripheral Oxygen Saturation (SpO₂)

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

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.

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.

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.

Airway Intervention Requirement

Need for airway maneuvers or ventilatory support during the procedure.

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

Unit: beats/min. Changes in heart rate during procedural sedation.

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

Unit: mmHg. Changes in blood pressure during procedural sedation.

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)

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.

Time frame: 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.

Time frame: 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.

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).