Severity of Aspiration in Post-extubated SubjectsNCT01849679
Post Extubation Dysphagia
An observational study of Severity of Aspiration in Post-extubated Subjects, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators hypothesize that aspiration will be more prevalent at two to four hours post-extubation but will resolve in the majority of patients by 24 to 26 hours post-extubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severity of Aspiration in Post-extubated Subjects
- What is being tested?
- Evaluation of Swallowing
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.
Who may be able to join
- Patients that were intubated for more than 48 hours.
- Adults, 18 and over
- All races
- Males and females
- Approval to participate in the study by the treating physician
Who cannot join
- Patients with a history of oropharyngeal dysphagia.
- Patients with neurological disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
- Patients with a history of head and neck cancer or laryngeal surgery.
- Patients that are not candidate for FEES because of facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk (patients on therapeutically dosed anticoagulant infusion or injection, platelet count less than 50,000, INR greater than 2.0, partial thromboplastin time greater than 1.5 times normal), decreased level of arousal/alertness, significant agitation, or inability to tolerate room air or nasal cannula oxygen for duration of FEES.
- Patients who are extubated after 1400 or on weekends (Friday, Saturday, or Sunday).
- Non-English Speakers will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Official title: The Effect on Time After Extubation on Aspiration Risk
The investigators hypothesize that aspiration will be more prevalent at two to four hours post-extubation but will resolve in the majority of patients by 24 to 26 hours post-extubation.
The purpose of the research is to investigate whether there is a difference in swallow function two to four hours after extubation (removal of breathing tube) compared to 24 hours after extubation. This information will help healthcare providers decide if it is necessary for people to wait 24 hours after extubation before they start eating and drinking.
- Being tested
- Evaluation of Swallowing
- Keywords
- Dysphagia, extubation, aspiration
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of SwallowingOther
Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration
| Study group | Role | What they receive |
|---|---|---|
| Post-Extubation Subjects | Not described Receives: Other: Evaluation of Swallowing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Aspiration per Evaluation
Flexible Endoscopic Evaluation of Swallow (FEES - a measure of swallowing which will allow for the diagnosis of swallowing) will be recorded at between 2 to 4 hour after extubation. If penetration/aspiration is noted during the evaluation between 2 to 4 hours post-extubation, then a second FEES evaluation will be completed between 24 to 26 hours post-extubation.
Measured: post-extubation at 2-4 hours and possibly 24-26 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severity of Aspiration in Post-extubated SubjectsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stevie Marvin, MS, Principal investigator, Univeristy of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849679
- Sponsor's protocol ID
- 2012-0407
- Status last verified
- Oct 2016
- First submitted
- 3 May 2013
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Time After Extubation on Aspiration Risk
- ClinicalTrials.gov ID
- NCT01849679
- Acronym / sponsor ID
- 2012-0407
- Keywords
- Dysphagia, extubation, aspiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that aspiration will be more prevalent at two to four hours post-extubation but will resolve in the majority of patients by 24 to 26 hours post-extubation.
The purpose of the research is to investigate whether there is a difference in swallow function two to four hours after extubation (removal of breathing tube) compared to 24 hours after extubation. This information will help healthcare providers decide if it is necessary for people to wait 24 hours after extubation before they start eating and drinking.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Extubation Subjects | – | Other: Evaluation of Swallowing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.
Key inclusion criteria (5 listed)
- Patients that were intubated for more than 48 hours.
- Adults, 18 and over
- All races
- Males and females
- Approval to participate in the study by the treating physician
Key exclusion criteria (6 listed)
- Patients with a history of oropharyngeal dysphagia.
- Patients with neurological disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
- Patients with a history of head and neck cancer or laryngeal surgery.
- Patients that are not candidate for FEES because of facial fractures, nothing by mouth (NPO) status for other procedures, elevated bleeding risk (patients on therapeutically dosed anticoagulant infusion or injection, platelet count less than 50,000, INR greater than 2.0, partial thromboplastin time greater than 1.5 times normal), decreased level of arousal/alertness, significant agitation, or inability to tolerate room air or nasal cannula oxygen for duration of FEES.
- Patients who are extubated after 1400 or on weekends (Friday, Saturday, or Sunday).
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 |
|---|---|---|
| Evaluation of SwallowingEvaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration | Other | Post-Extubation Subjects |
Primary outcome
Severity of Aspiration per Evaluation
Time frame: post-extubation at 2-4 hours and possibly 24-26 hours.
Flexible Endoscopic Evaluation of Swallow (FEES - a measure of swallowing which will allow for the diagnosis of swallowing) will be recorded at between 2 to 4 hour after extubation. If penetration/aspiration is noted during the evaluation between 2 to 4 hours post-extubation, then a second FEES evaluation will be completed between 24 to 26 hours post-extubation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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.
Stevie Marvin, MS principal investigator
Univeristy of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severity of Aspiration in Post-extubated Subjects, run by University of Wisconsin, Madison 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 5 inclusion and 6 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 1 Nov 2016. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severity of Aspiration per Evaluation (time frame: post-extubation at 2-4 hours and possibly 24-26 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2016.