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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

Tracking Information
First Submitted Date May 3, 2013
First Posted Date May 8, 2013
Last Update Posted Date November 1, 2016
Study Start Date March 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2013)
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.
Original Primary Outcome Measures
 (submitted: May 7, 2013)
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 penetation/aspiration is noted during the evaluation between 2 to 4 hours post-extubation, then a second FEES evalutation will be completed between 24 to 26 hours post-extubation.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post Extubation Dysphagia
Official Title The Effect on Time After Extubation on Aspiration Risk
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.
Condition Severity of Aspiration in Post-extubated Subjects
Intervention Other: Evaluation of Swallowing
Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration
Study Groups/Cohorts Post-Extubation Subjects
Intervention: Other: Evaluation of Swallowing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 31, 2016)
71
Original Estimated Enrollment
 (submitted: May 7, 2013)
100
Actual Study Completion Date February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01849679
Other Study ID Numbers 2012-0407
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators Not Provided
Investigators
Principal Investigator: Stevie Marvin, MS Univeristy of Wisconsin
PRS Account University of Wisconsin, Madison
Verification Date October 2016