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

Not Applicable

Completed

• Conditions: Respiratory Failure

• Registration Number: NCT02284178
• Lead Sponsor: University of Central Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Primary Completion: 2017-08
• Study Completion: 2017-12
• Results First Submitted: 2019-06-05
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Results First Posted: 2019-08-15
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Microaspiration as Measured by Tracheal Amylase	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	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 Outcome Measures

Name	Time	Method
Time to VAC	VAC was assessed for two days beyond the last intervention; mean 5.4 days
Ventilator-Associated Condition (VAC) Rate	VAC assessed for 2 days beyond last intervention; mean 5.4 days	VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.

Trial Locations

Locations (1)

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States