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

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 Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Enhanced oropharyngeal suction; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced oral suction; Deep oropharyngeal suction with catheter	Other: Enhanced oropharyngeal suction; Deep oropharyngeal suction with catheter every 4 hours
Sham Comparator: Usual Care Oral Suction; Oropharyngeal suction with suction swab	Other: Usual Care; Oral suction with suction swab every 4 hours

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: Orlando Regional Medical Center
• Investigators: Principal Investigator: Mary L Sole, PhD, Univesity of Central Florida

Publications and helpful links

General Publications

• Bourgault AM, Xie R, Talbert S, Sole ML. Association of enteral feeding with microaspiration in critically ill adults. Appl Nurs Res. 2022 Oct;67:151611. doi: 10.1016/j.apnr.2022.151611. Epub 2022 Jun 30.
• Talbert S, Bourgault AM, Rathbun KP, Abomoelak B, Deb C, Mehta D, Sole ML. Pepsin A in Tracheal Secretions From Patients Receiving Mechanical Ventilation. Am J Crit Care. 2021 Nov 1;30(6):443-450. doi: 10.4037/ajcc2021528.
• Sole ML, Talbert S, Yan X, Penoyer D, Mehta D, Bennett M, Emery KP, Middleton A, Deaton L, Abomoelak B, Deb C. Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial. J Adv Nurs. 2019 Nov;75(11):3045-3057. doi: 10.1111/jan.14142. Epub 2019 Aug 7.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: mechanical ventilation; secretions; aspiration; suctioning; ventilator-associated events
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 1R01NR014508-01A1 (U.S. NIH Grant/Contract)