Status:
WITHDRAWN
Validation of Aspiration Markers
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Pneumonia, Aspiration
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an interventional crossover study aimed at validating diatom shells as a marker for cuff leak and microaspiration in mechanically ventilated, critically ill patients.
Detailed Description
At present there is no standard method for the evaluation of in vivo cuff leak and aspiration. Most of the tested techniques have major pitfalls that render their routine application infeasible. Lacki...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Admission to Surgical ICUs (Ellison 4 or Blake 12);
- Patients expected to be intubated for at least 48 hours or longer from the time of enrollment.
Exclusion
- High PEEP requirement at enrollment (PEEP higher than 8 cmH2O)
- Diagnosis of ARDS (any severity)
- Status asthmaticus
- Current or past participation in another interventional trial conflicting with the present study;
- Pregnant women;
- Prisoner status;
- Patients who had partial or total gastrectomy.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02301845
Start Date
February 1 2016
End Date
March 1 2016
Last Update
March 16 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114