Validation of Aspiration Markers

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

1. Age ≥ 18 years;

2. Admission to Surgical ICUs (Ellison 4 or Blake 12);

3. Patients expected to be intubated for at least 48 hours or longer from the time of enrollment.

Exclusion Criteria:

1. High PEEP requirement at enrollment (PEEP higher than 8 cmH2O)

2. Diagnosis of ARDS (any severity)

3. Status asthmaticus

4. Current or past participation in another interventional trial conflicting with the present study;

5. Pregnant women;

6. Prisoner status;

7. Patients who had partial or total gastrectomy.