HFNO Flow Rates and Cerebral Oxygenation During Deep Sedation for Cystoscopy

NCT07630038 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-05

No results posted yet for this study

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.

Conditions

  • Deep Sedation
  • High Flow Nasal Canula
  • Cerebral Oxygenation
  • PSI

Interventions

DEVICE

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.

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Firat University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-09-01
Completion
2026-10-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630038 on ClinicalTrials.gov