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Post Extubation Dysphagia

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ClinicalTrials.gov Identifier: NCT01849679
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

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.


Condition or disease Intervention/treatment
Severity of Aspiration in Post-extubated Subjects Other: Evaluation of Swallowing

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect on Time After Extubation on Aspiration Risk
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Group/Cohort Intervention/treatment
Post-Extubation Subjects Other: Evaluation of Swallowing
Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849679


Locations
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United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Stevie Marvin, MS Univeristy of Wisconsin

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01849679     History of Changes
Other Study ID Numbers: 2012-0407
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by University of Wisconsin, Madison:
Dysphagia
extubation
aspiration