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

Respiratory Failure Clinical Trial

— NO-ASPIRATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284178
• Other study ID #: 1R01NR014508-01A1
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: University of Central Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 513
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• Enhanced oropharyngeal suction
Deep oropharyngeal suction with catheter every 4 hours
• Usual Care
Oral suction with suction swab every 4 hours

Locations

Country	Name	City	State
United States	Orlando Regional Medical Center	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Central Florida	Orlando Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tracheal to Oral Ratio of Amylase	The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).	Every 12 hours up to 14 days
Primary	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
Primary	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	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
Secondary	Time to VAC		VAC was assessed for two days beyond the last intervention; mean 5.4 days