WithdrawnPhase 1

Validation of Aspiration Markers in Intubated Patients

Stopped: Lack of funding

United States0Started 2015-12

Plain-language summary

The goal of this interventional study is to test Quinine as marker of aspiration (endotracheal tube \[ETT\] cuff leakage) in mechanically ventilated, critically ill patients.

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: * Age ≥ 18 years * Admission to Surgical ICUs (MGH Ellison 4 or Blake 12) * Patients expected to be intubated for at least 48 hours or longer from the time of enrollment. Exclusion Criteria: * High PEEP requirement at enrollment (PEEP higher than 8 cmH2O) * Diagnosis of ARDS (any severity) * Status asthmatics * Current or past participation in another interventional trial conflicting with the present study * Pregnant women * Prisoner status * Patients who had partial or total gastrectomy.

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

Oropharyngeal aspiration: change in concentration of quinine in tracheal samples.

Timeframe: After the beginning of the study, samples will be collected at hours: 0,1 and 24, 25

Trial details

NCT IDNCT02598713

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Pneumonia trials

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.