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Clinical Trials/NCT01849679
NCT01849679CompletedNot Applicable

The Effect on Time After Extubation on Aspiration Risk

University of Wisconsin, Madison1 site in 1 country71 target enrollmentStarted: March 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
71
Locations
1
Primary Endpoint
Severity of Aspiration per Evaluation

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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