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

Study Overview
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Brief Summary
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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.

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

Conditions
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Respiratory Failure

Intervention / Treatment
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* Other: Enhanced oropharyngeal suction
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced oral suction<br>Deep oropharyngeal suction with catheter | Other: Enhanced oropharyngeal suction<br>* Deep oropharyngeal suction with catheter every 4 hours<br>|
| Sham Comparator: Usual Care Oral Suction<br>Oropharyngeal suction with suction swab | Other: Usual Care<br>* Oral suction with suction swab every 4 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microaspiration as Measured by Tracheal Amylase | 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. | Every 12 hours up to 14 days | 
| Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant | Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria | Every 12 hours up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-Associated Condition (VAC) Rate | VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events