Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Total duration of lens-fog interruptions (minutes)
研究概览
简要总结
The goal of this clinical trial is to learn if the anti-fog suction device works to keep the surgical view clear during endoscopic nose-to-pituitary operations and whether it lowers the chance of brain-fluid infection. It will also learn about the safety of the device.
The main questions it aims to answer are:
- Does the device reduce the total time the surgeon has to stop because the lens fogs up?
- What medical problems (such as nose-bleed, tube blockage, or infection) do participants have when the device is used?
Researchers will compare the anti-fog device to the usual "water-squirt" method to see if the device works better.
Participants will:
- Have either the device or the usual water method applied during their planned pituitary surgery
- Stay in the hospital for the normal recovery period (about 3-5 days) and return for a routine check-up around day 7
- Allow the study team to record operating times, any fog-related pauses, and results of blood or spinal-fluid tests taken before and after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Pre-operative MRI/CT diagnosis of pituitary adenoma or craniopharyngioma ≤ *3 cm without extensive skull-base invasion
- •Scheduled for elective endoscopic endonasal transsphenoidal resection
- •ASA physical status I-III
- •Able and willing to give written informed consent and comply with follow-up
排除标准
- •Severe nasal anatomical deformity, polyps, or prior nasal surgery preventing device placement
- •Active nasal or systemic infection (WBC > 10 × 10⁹/L, CRP ≥ 10 mg/L)
- •Known intracranial infection or ongoing CSF leak
- •Coagulopathy (PT > 14 s or APTT > 45 s) or anticoagulation that cannot be stopped ≥ 7 days
- •Allergy to silicone or medical-grade plastics
- •Planned combined transcranial or transorbital approach
- •Pregnancy or breastfeeding
- •Psychiatric or cognitive disorder precluding informed consent or follow-up
研究组 & 干预措施
Intervention group
A single-use, sterile "anti-fog suction device" (a 4 Fr multi-channel silicone catheter) is introduced through the same nostril alongside the endoscope after induction of anaesthesia.
The built-in micro-balloon is inflated with 1 ml air to anchor the tip in the posterior choana.
Low-flow (2 L min-¹), filtered, room-temperature air is delivered through the central lumen, creating a gentle laminar stream that passes across the lens, continuously removing warm humid air and preventing condensation.
Two side ports provide continuous low-pressure (-5 cmH₂O) suction of any blood or fluid, keeping the surgical field dry.
The device remains in place for the entire operation and is removed before nasal packing. No extra incisions or sutures are required.
干预措施: Anti-fog suction device-a 4 Fr multi-channel silicone catheter (Device)
Control group
Standard care: whenever the lens fogs, the scrub nurse withdraws the endoscope and irrigates its tip with 5-10 ml of 37 °C sterile saline from a 20 ml syringe. This manoeuvre is repeated as often as necessary (average 10-15 times per case).
结局指标
主要结局
Total duration of lens-fog interruptions (minutes)
时间窗: Before the Nasal Packing(2 hours roughly)
defined as the cumulative time from the moment the surgeon declares "lens fogged" until clear operative view is restored, measured with a stop-watch by the circulating nurse throughout the entire endoscopic endonasal procedure.
次要结局
- post-operative intracranial infection rate(7 days)
- Total irrigation fluid volume used intra-operatively (ml)(Before the nasal packing(2 hours roughly))
研究者
Zhigang Lan
Professor
West China Hospital