Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients (NCT02116491) | Clinical Trial Compass
UnknownPhase 1
Visual Sputum Suctioning System Tests in Mechanically Ventilated Patients
China40 participantsStarted 2014-03
Plain-language summary
BACKGROUND: The investigators developed a fiber-optic-guided endotracheal suction catheter (visual sputum suctioning system or VSSS), which the investigators previously tested in vitro and animals. It integrates a 0.9-mm micro-imaging fiber into a 3.7-mm double-lumen catheter.
PURPOSE: The purpose of this study was to investigate the safety and efficacy of sputum suctioning system in mechanical ventilated patients in respiratory intensive care unit (RICU). The investigators compare the weight of secretions collected, vital signs, and tracheal wall injury between two groups of patients randomized to have VSSS combined with closed system suction (CSC) suction and patients having CSC suction alone.
HYPOTHESIS: The investigators theorized that the VSSS collected more sputum and caused less change of vital signs than conventional CSC.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients admitted to RICU
* 18 years old or more
* Ventilated more than 24 hours mechanical ventilation
* Patients with stability (MAP\>70 mmHg, HR\<130 b/min)
* Signed informed consent
Exclusion Criteria:
* Current or past participation in another intervention trial conflicting with the present study patients with stupor and coma
* Any clinical events or practitioner interventions within 15 min prior to study enrollment (eg, a change in ventilator settings, hemodynamic instability \[DBP \>100 mmHg; ↑or 20mmHg in PaO2; ↑20 b/min in HR\]; sever hypoxemia \[SpO2\<85%, PaO2\<50mmHg\])
* Had heart or lung or heart transplantation.
* Had massive hemoptysis.
* Pregnant women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in hemodynamic and respiratory data at 5 min
Timeframe: Patients will be followed until 2 hour after suction.
2
Rate of hemorrhage
Timeframe: Patients will be followed until 2 hour after suction.
Trial details
NCT IDNCT02116491
SponsorFirst Affiliated Hospital of Chongqing Medical University