Status:
COMPLETED
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Lead Sponsor:
University of Central Florida
Collaborating Sponsors:
Orlando Regional Medical Center
Conditions:
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
513 Patients enrolled
Trial Details
Trial ID
NCT02284178
Start Date
August 1 2014
End Date
December 1 2017
Last Update
August 15 2019
Active Locations (1)
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1
Orlando Regional Medical Center
Orlando, Florida, United States, 32806