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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究者
AHMET AKSU
Assistant Professor
Firat University