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Effect of High-Flow Nasal Oxygen on Laryngoscopic View

2026年5月4日 更新者:Michal Kalina、Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

Effect of Different Flows Using High-Flow Nasal Oxygen (HFNO) on Laryngoscopic View Quality During Videolaryngoscopy

This prospective, multicenter observational study aims to evaluate the effect of different flow rates of high-flow nasal oxygen (HFNO) on the quality of the laryngoscopic view during videolaryngoscopy in adult patients undergoing general anesthesia. Each patient will serve as their own control, with repeated measurements obtained at three different HFNO flow settings (0, 40, and 60 L/min). The study will assess objective and subjective parameters of glottic visualization using standardized scoring systems.

研究概览

详细说明

Anaesthetic management Anaesthesia induction and airway management will be standardized as far as clinically feasible. Standard monitoring will be applied according to institutional practice. Preoxygenation will be performed using high-flow nasal oxygen (HFNO). General anaesthesia will be induced using standard intravenous agents, followed by administration of neuromuscular blockade to facilitate laryngoscopy. Mask ventilation will be performed as clinically indicated.

Videolaryngoscopy will be performed using a standardized device and blade type whenever possible. All procedures will be performed by anesthesiologists experienced in videolaryngoscopy.

Study procedure

After induction of anaesthesia and achievement of adequate conditions for laryngoscopy, videolaryngoscopy will be performed. During a single laryngoscopic sequence, images of the laryngeal view will be obtained under three predefined HFNO flow conditions:

  • 0 L/min
  • 40 L/min
  • 60 L/min At each flow level, once a stable laryngeal view will be achieved, a still image will be captured using the videolaryngoscope recording system. The laryngoscope position will be maintained as stable as possible during acquisition of all three images. No attempt at tracheal intubation will be made during image acquisition.

After completion of the image capture protocol, tracheal intubation will be performed according to standard clinical practice.

All images will be anonymized and stored for subsequent offline analysis. Image assessment Captured images will be evaluated offline by an independent anesthesiologist blinded to HFNO flow rates and patient identity. Where applicable, evaluation will be performed by more than one assessor to allow assessment of inter-rater agreement.

Each image will be assessed using predefined objective and subjective measures (Percentage of Glottic Opening, Likert scale).

研究类型

观察性的

注册 (估计的)

150

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients undergoing elective surgical procedures requiring endotracheal intubation under general anesthesia.

描述

Inclusion Criteria:

  • Age ≥18 years
  • Scheduled for endotracheal intubation under general anesthesia
  • Use of videolaryngoscopy

Exclusion Criteria:

  • Anticipated difficult airway
  • Emergency intubation
  • Contraindications to HFNO
  • Inability to obtain adequate video recording

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Group HFNO
Adult patients with HFNO support for airway management
Different flows will be applied to patients undergoing general anaesthesia during airway management. In this arm flow will be 0 l/min. During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management. In this arm flow will 40 l/min. During these flows images will be captured using videolaryngoscope.
Different flows will be applied to patients undergoing general anaesthesia during airway management. In this arm flow will 60 l/min. During these flows images will be captured using videolaryngoscope.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality of view
大体时间:From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
Percentage of glottic opening (POGO score) assessed from recorded videolaryngoscopic images.
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).

次要结果测量

结果测量
措施说明
大体时间
Cormack-Lehane classification
大体时间:From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
Ordinal grading of glottic view using Cormack- Lehane classification.
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
Subjective image quality (Likert scale)
大体时间:From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).
Subjective assessment of laryngoscopic image quality rated on a 5-point Likert scale (1 = very poor, 5 = excellent) by independent evaluators blinded to HFNO flow conditions
From induction of general anesthesia to completion of orotracheal intubation (not longer than 10 minutes).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月4日

首先提交符合 QC 标准的

2026年5月4日

首次发布 (实际的)

2026年5月8日

研究记录更新

最后更新发布 (实际的)

2026年5月8日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • HFNORCT

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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