Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Anti-fog suction device-a 4 Fr multi-channel silicone catheter
DeviceA 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Total duration of lens-fog interruptions (minutes)
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.
Time frame
Before the Nasal Packing(2 hours roughly)Secondary outcomes
1
post-operative intracranial infection rate
Incidence of post-operative intracranial infection within 7 days (positive CSF culture OR CSF WBC ≥ 10 × 10⁶/L with fever ≥ 38.5 °C).
Time frame
7 days2
Total irrigation fluid volume used intra-operatively (ml)
Total irrigation fluid volume used intra-operatively (ml)
Time frame
Before the nasal packing(2 hours roughly)Sponsors and contacts
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Source ClinicalTrials.gov