Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 513
- Locations
- 2
- Primary Endpoint
- Microaspiration as Measured by Tracheal Amylase
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Enhanced oral suction
Deep oropharyngeal suction with catheter
Intervention: Enhanced oropharyngeal suction (Other)
Usual Care Oral Suction
Oropharyngeal suction with suction swab
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Microaspiration as Measured by Tracheal Amylase
Time Frame: Every 12 hours up to 14 days
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
Time Frame: Every 12 hours up to 14 days
Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria
Secondary Outcomes
- Ventilator-Associated Condition (VAC) Rate(VAC assessed for 2 days beyond last intervention; mean 5.4 days)
- Time to VAC(VAC was assessed for two days beyond the last intervention; mean 5.4 days)