Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE (NCT02284178) | Clinical Trial Compass
CompletedNot Applicable
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
United States513 participantsStarted 2014-08
Plain-language summary
Insertion of a breathing tube to enable treatment with mechanical ventilation (respirator) is often associated with complications, such as infection and lung injury. Leakage of secretions around the breathing tube (microaspiration) is a major factor leading to complications. The investigators propose that a standardized, enhanced oral suction protocol will be effective in reducing microaspiration and harms associated with mechanical ventilation. The investigators hypothesize that those randomized to the enhanced oral suction protocol will have less microaspiration and other ventilator-associated conditions than those in the usual care, standard suction group.
Who can participate
Age range
18 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:
* 18 years of age or older
* orally intubated with endotracheal tube and treated with mechanical ventilation
* 24 hours or less since intubation
* expected to be intubated for at least 36 hours after enrollment
Exclusion Criteria:
* documented aspiration at time of intubation
* intubation to treat known aspiration
* treatment with rescue mechanical ventilation therapies (oscillator)
* re-intubation
* contraindications to receiving the intervention (e.g., oral injuries)
* history of lung or head/neck cancers that may produce amylase in the lungs
* history of disease that affects saliva production (e.g., Sjögren's syndrome)
* prisoners
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
Microaspiration as Measured by Tracheal Amylase
Timeframe: Every 12 hours up to 14 days
2
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant