이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy

2026년 6월 1일 업데이트: AHMET AKSU, Firat University

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.

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 터키 (Türkiye)
    • Elaziğ
      • Elâzığ, Elaziğ, 터키 (Türkiye), 23100
        • Fırat University Faculty of Medicine Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 상영
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: HF40
Participants receive high-flow nasal oxygen (HFNO) therapy at a flow rate of 40 L/min during procedural sedation for cystoscopy.
장치: 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.
실험적: HF55
Participants receive HFNO therapy at a flow rate of 55 L/min during procedural sedation for cystoscopy.
장치: 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.
실험적: HF70
Participants receive HFNO therapy at a flow rate of 70 L/min during procedural sedation for cystoscopy.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Regional Cerebral Oxygen Saturation (rSO₂)
기간: 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.
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.

2차 결과 측정

결과 측정
측정값 설명
기간
Peripheral Oxygen Saturation (SpO₂)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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
기간: 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.
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
기간: 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.
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
기간: 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.
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
기간: 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.
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)
기간: 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.
From the initiation of sedation until the end of the cystoscopy procedure.
Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Score
기간: 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.
From the initiation of sedation until the end of the cystoscopy procedure.
Patient Satisfaction
기간: 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.
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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Firat University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 10월 1일

연구 등록 날짜

최초 제출

2026년 5월 22일

QC 기준을 충족하는 최초 제출

2026년 6월 1일

처음 게시됨 (실제)

2026년 6월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 47669

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다