Air vs. Liquid: A Study on Cystoscopy Performance and Visibility Enhancement in Macrohematuria Cases (AIROSCOPY)
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).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lasse Petersen, Dr. med. univ.
- 電話番号：+41 56 486 3083
- メール：lasse.petersen@ksb.ch
研究場所
-
-
Canton of Aargau
-
Baden、Canton of Aargau、スイス、5404
- Kantonsspital Baden AG, Department of Urology
-
コンタクト：
- Lasse Petersen, Dr.med. univ.
- 電話番号：0041 56 486 3083
- メール：lasse.petersen@ksb.ch
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
Flexible cystoscopy with manual air insufflation (up to 240 ml) via bladder syringe for bladder distension and visualisation.
|
|
アクティブコンパレータ：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.
|
Flexible cystoscopy with manual saline irrigation (up to 240 ml, 0.9% NaCl) via bladder syringe for bladder distension and visualisation.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identification of the underlying cause of macroscopic haematuria during the index cystoscopy
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to source identification
時間枠：Intraoperative
|
Minutes from insertion of the cystoscope to first identification of the bleeding source during the index cystoscopy.
|
Intraoperative
|
|
Total procedure duration
時間枠：Intraoperative
|
Minutes from insertion to removal of the cystoscope during the index cystoscopy.
|
Intraoperative
|
|
Urologist-rated visibility
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-00787 (その他の識別子：EKNZ (Ethikkommission Nordwest- und Zentralschweiz))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。