Clinical trial NCT02284178: Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Official title: Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: mechanical ventilation
aspiration
suctioning
secretions
ventilator-associated events
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Orlando Regional Medical Center
First posted: 2014-11-05
Enrollment: 513
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Microaspiration as Measured by Tracheal Amylase
timeFrame: Every 12 hours up to 14 days
measure: Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
timeFrame: Every 12 hours up to 14 days
Secondary outcomes:
measure: Ventilator-Associated Condition (VAC) Rate
timeFrame: VAC assessed for 2 days beyond last intervention; mean 5.4 days
measure: Time to VAC
timeFrame: VAC was assessed for two days beyond the last intervention; mean 5.4 days
Other outcomes:
measure: Tracheal to Oral Ratio of Amylase
timeFrame: Every 12 hours up to 14 days
Locations:
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
Study officials:
affiliation: Univesity of Central Florida
name: Mary L Sole, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.