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

University of Central Florida513 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

513

Conditions

Respiratory Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: Every 12 hours up to 14 days

Secondary Outcomes

Ventilator-Associated Condition (VAC) Rate

VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.

Time frame: VAC assessed for 2 days beyond last intervention; mean 5.4 days

Time to VAC

Time frame: VAC was assessed for two days beyond the last intervention; mean 5.4 days