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Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases (AIROSCOPY)

2026年5月31日 更新者：Lukas J Hefermehl、Kantonsspital Baden

AIROSCOPY - A Prospective, Randomized, Controlled, Single-Centre Superiority Study Comparing Air-Based Versus Saline-Based Flexible Cystoscopy for the Identification of the Bleeding Source in Patients With Macroscopic Haematuria

Macroscopic haematuria is a common urological emergency. Diagnostic cystoscopy is the gold standard for identifying the bleeding source; however, blood and clots within the bladder significantly impair endoscopic visibility when saline is used as the distension medium.

Air-based cystoscopy, a technique first described in the 19th century, exploits the immiscibility of gas and blood to maintain clear visualisation even during active bleeding. Despite its theoretical advantages, no randomised clinical data exist to support its use.

AIROSCOPY is a prospective, randomised, controlled, single-centre superiority study comparing air-based versus saline-based flexible cystoscopy in patients with macroscopic haematuria (Grade III-V). Patients are randomised 1:1. Only the index cystoscopy (first randomised modality) contributes to all study endpoints. A second cystoscopy with the alternative modality is performed solely for patient safety to ensure no diagnostic disadvantage from study participation. This second examination is not analysed.

The primary endpoint is identification of the bleeding source during the index cystoscopy (binary: yes/no). Secondary endpoints include time to source identification, total procedure duration, urologist-rated visibility (Likert scale), and patient comfort (Likert scale).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Background: Continuous bladder irrigation (CBI) is the current standard management for haematuria, but can delay diagnostic cystoscopy. Gas-based cystoscopy may allow earlier and clearer visualisation of the bladder mucosa.

Design: Prospective, randomised (1:1), controlled, parallel-group, open-label, single-centre superiority trial. Randomisation is stratified by haematuria grade and history of transurethral resection (TUR-B/P), using REDCap.

Intervention: Index cystoscopy with either air (up to 240 ml by syringe) or saline (up to 240 ml by syringe), according to randomisation. A second cystoscopy with the alternative medium follows immediately, exclusively to ensure no diagnostic disadvantage for the patient (results not analysed).

Sample size: N=40 (20 per arm), based on detection rates of 86% (air) vs. 38% (saline), two-sided α=0.05, 80% power, with 20% attrition allowance.

Statistics: Chi-square test (Fisher's exact test) for the primary endpoint; risk ratio and risk difference with 95% CI reported.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 瑞士
    • Canton of Aargau
      • Baden、Canton of Aargau、瑞士、5404
        • Kantonsspital Baden AG, Department of Urology
        • 接触：

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

描述

Inclusion Criteria:

  • Persistent macroscopic haematuria Grade III-V within 48 hours after hospitalisation
  • Age ≥ 18 years
  • Unexplained macroscopic haematuria requiring diagnostic cystoscopy
  • Ability to give written informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Haemodynamic instability or urgent need for operative or interventional cystoscopy (requiring cystoscopy within < 24 hours of screening)
  • Ureteral stent in situ
  • Active urinary tract infection
  • Transurethral resection of the bladder (TURB) or prostate (TURP) within the last 6 weeks

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

  • 主要用途：诊断
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Air Cystoscopy
Flexible cystoscopy using air as the distension medium (up to 240 ml, manually administered via bladder syringe). This is the index cystoscopy for patients randomised to air.
程序：Air-based flexible cystoscopy
Flexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
有源比较器：Saline Cystoscopy
Flexible cystoscopy using 0.9% saline as the distension medium (up to 240 ml, manually administered via bladder syringe). Standard-of-care procedure. This is the index cystoscopy for patients randomised to saline.
程序：Saline-based flexible cystoscopy
Flexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.

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
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
大体时间：Immediately after completion of the index cystoscopy (intraoperative)
Binary outcome (yes/no). Assessed in real time by the operating urologist during the index procedure and documented immediately after completion. 'Yes' if a specific bleeding source (e.g., tumour, prostate bleeding, stone, vascular lesion) is identified; 'No' otherwise.
Immediately after completion of the index cystoscopy (intraoperative)

次要结果测量

结果测量
措施说明
大体时间
Time to source identification
大体时间：Intraoperative
Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
Intraoperative
Total procedure duration
大体时间：Intraoperative
Minutes from insertion to removal of the cystoscope during the index cystoscopy.
Intraoperative
Urologist-rated visibility
大体时间：Immediately after index cystoscopy
5-point Likert scale (1 = very poor to 5 = excellent), completed by the operating urologist immediately after the index cystoscopy.
Immediately after index cystoscopy
Patient comfort
大体时间：Immediately after index cystoscopy
Description: 5-point Likert scale (1 = very uncomfortable to 5 = very comfortable), completed by the patient immediately after the index cystoscopy.
Immediately after index cystoscopy

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。

赞助

Kantonsspital Baden

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7月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年5月25日

首次发布 (实际的)

2026年6月1日

研究记录更新

最后更新发布 (实际的)

2026年6月3日

上次提交的符合 QC 标准的更新

2026年5月31日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2026-00787 (其他标识符：EKNZ (Ethikkommission Nordwest- und Zentralschweiz))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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