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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced oropharyngeal suction
Usual Care
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orlando Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Enhanced oral suction

Usual Care Oral Suction

Arm Description

Deep oropharyngeal suction with catheter

Oropharyngeal suction with suction swab

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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 to VAC

Full Information

First Posted
October 15, 2014
Last Updated
July 23, 2019
Sponsor
University of Central Florida
Collaborators
Orlando Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02284178
Brief Title
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Acronym
NO-ASPIRATE
Official Title
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
Orlando Regional Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
513 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced oral suction
Arm Type
Experimental
Arm Description
Deep oropharyngeal suction with catheter
Arm Title
Usual Care Oral Suction
Arm Type
Sham Comparator
Arm Description
Oropharyngeal suction with suction swab
Intervention Type
Other
Intervention Name(s)
Enhanced oropharyngeal suction
Intervention Description
Deep oropharyngeal suction with catheter every 4 hours
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Oral suction with suction swab every 4 hours
Primary Outcome Measure Information:
Title
Microaspiration as Measured by Tracheal Amylase
Description
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
Title
Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant
Description
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 Outcome Measure Information:
Title
Ventilator-Associated Condition (VAC) Rate
Description
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
Title
Time to VAC
Time Frame
VAC was assessed for two days beyond the last intervention; mean 5.4 days
Other Pre-specified Outcome Measures:
Title
Tracheal to Oral Ratio of Amylase
Description
The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).
Time Frame
Every 12 hours up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary L Sole, PhD
Organizational Affiliation
Univesity of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36116866
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.
Results Reference
derived
PubMed Identifier
34719715
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.
Results Reference
derived
PubMed Identifier
31241194
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.
Results Reference
derived

Learn more about this trial

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

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