Cerebral Oxygenation, Deep Sedation, High Flow Nasal Canula, PSI
Conditions
Keywords
High Flow Nasal Canula, Deep Sedation, rSO2, PSI
Brief 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. 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.
Interventions
DEVICEHigh-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.
DEVICEHigh-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.
DEVICEHigh-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.
Sponsors
Firat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patients, surgeons, and outcome assessors were blinded to group allocation. Randomization codes were placed in sealed envelopes, and the assigned HFNO flow rate was known only to the anesthesiologist administering the intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Regional Cerebral Oxygen Saturation (rSO₂) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Oxygen Saturation (SpO₂) | 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: % . Evaluation of peripheral oxygenation levels during procedural sedation. |
| Partial arterial carbon dioxide pressure (PaCO₂) | 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. | Unit: mmHg. Assessment of arterial carbon dioxide pressure levels during sedation. |
| End-tidal carbon dioxide (EtCO₂) | 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. | Unit: mmHg. Assessment of end-tidal carbon dioxide levels during sedation. |
| Incidence of Hypoxemia | 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. | Frequency of hypoxemia episodes defined as SpO₂ \<90% or \>20% decrease in rSO₂ from baseline. |
| Airway Intervention Requirement | 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. | Need for airway maneuvers or ventilatory support during the procedure. |
| Heart Rate | From baseline before sedation until the end of the cystoscopy procedure. Heart rate will be recorded continuously during the intraoperative sedation period. | Unit: beats/min. Changes in heart rate during procedural sedation. |
| Mean Arterial Pressure | From baseline before sedation until the end of the cystoscopy procedure. Blood pressure, will be recorded continuously during the intraoperative sedation period. | Unit: mmHg. Changes in blood pressure during procedural sedation. |
| Patient State Index (PSI) | From the initiation of sedation until the end of the cystoscopy procedure. | 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. |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score | From the initiation of sedation until the end of the cystoscopy procedure. | 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. |
| Patient Satisfaction | 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). | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAhmet Aksu, Assistant Professor
Outcome results
None listed