Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE

University of Central Florida

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: Enhanced oropharyngeal suction; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02284178

1R01NR014508-01A1

Details and patient eligibility

About

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.

Enrollment: 513 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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513 participants in 2 patient groups

Enhanced oral suction

Experimental group

Description:

Deep oropharyngeal suction with catheter

Treatment:

Other: Enhanced oropharyngeal suction

Usual Care Oral Suction

Sham Comparator group

Description:

Oropharyngeal suction with suction swab

Treatment:

Other: Usual Care