N/A
N=513
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02284178 ↗Enrolled (actual)
513
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Microaspiration as Measured by Tracheal Amylase — 13,086; 15,298 U/L — p=0.432
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced oropharyngeal suction (Other); Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Central Florida
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microaspiration as Measured by Tracheal Amylase |
13,086; 15,298 | 0.432 |
| PRIMARY Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant |
75.2; 78.4 | 0.684 |
| SECONDARY Ventilator-Associated Condition (VAC) Rate |
31; 32 | 0.858 |
| SECONDARY Time to VAC |
4.94; 5.72 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02284178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.