Respiratory FailureNO-ASPIRATENCT02284178
Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
A study testing Enhanced oropharyngeal suction in people with Respiratory Failure, run by University of Central Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Enhanced oropharyngeal suction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 513 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Regional Medical Center
Orlando, Florida, 32806
About this study
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.
- Conditions
- Respiratory Failure
- Being tested
- Enhanced oropharyngeal suction, Usual Care
- Keywords
- mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced oropharyngeal suctionOther
Deep oropharyngeal suction with catheter every 4 hours
Usual CareOther
Oral suction with suction swab every 4 hours
| Study group | Role | What they receive |
|---|---|---|
| Enhanced oral suction | Experimental | Deep oropharyngeal suction with catheter Receives: Other: Enhanced oropharyngeal suction |
| Usual Care Oral Suction | Sham comparator | Oropharyngeal suction with suction swab Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Every 12 hours up to 14 days
Secondary outcomes (2)
Ventilator-Associated Condition (VAC) Rate
VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.
Measured: VAC assessed for 2 days beyond last intervention; mean 5.4 days
Time to VAC
Measured: VAC was assessed for two days beyond the last intervention; mean 5.4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Orlando Regional Medical Center
- Responsible party
- Sponsor
- Investigators
- Mary L Sole, PhD, Principal investigator, Univesity of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284178
- Sponsor's protocol ID
- 1R01NR014508-01A1
- Acronym
- NO-ASPIRATE
- Status last verified
- Jul 2019
- First submitted
- 15 Oct 2014
- Last updated
- 15 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 36116866Talbert 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.
PubMed 34719715Sole 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.
PubMed 31241194
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE
- ClinicalTrials.gov ID
- NCT02284178
- Acronym / sponsor ID
- NO-ASPIRATE / 1R01NR014508-01A1
- Conditions
- Respiratory Failure
- Keywords
- mechanical ventilation, aspiration, suctioning, secretions, ventilator-associated events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Orlando Regional Medical Center
- Study start
- Aug 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Posted 15 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced oral suction | Experimental | Other: Enhanced oropharyngeal suctionDeep oropharyngeal suction with catheter |
| Usual Care Oral Suction | Sham comparator | Other: Usual CareOropharyngeal suction with suction swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced oropharyngeal suctionDeep oropharyngeal suction with catheter every 4 hours | Other | Enhanced oral suction |
| Usual CareOral suction with suction swab every 4 hours | Other | Usual Care Oral Suction |
Primary outcome
Microaspiration as Measured by Tracheal Amylase
Time frame: 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
Time frame: 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
2 secondary outcomes
Ventilator-Associated Condition (VAC) Rate
Time frame: VAC assessed for 2 days beyond last intervention; mean 5.4 days
Time to VAC
Time frame: VAC was assessed for two days beyond the last intervention; mean 5.4 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36116866Bourgault 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.
- Derived from this study: PubMed 34719715Talbert 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.
- Derived from this study: PubMed 31241194Sole 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary L Sole, PhD principal investigator
Univesity of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced oropharyngeal suction in people with Respiratory Failure, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microaspiration as Measured by Tracheal Amylase (time frame: Every 12 hours up to 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284178, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.