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Post Extubation Dysphagia

The Effect on Time After Extubation on Aspiration Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01849679
Enrollment
71
Registered
2013-05-08
Start date
2013-03-31
Completion date
2016-02-29
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severity of Aspiration in Post-extubated Subjects

Keywords

Dysphagia, extubation, aspiration

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.

Interventions

OTHEREvaluation of Swallowing

Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Severity of Aspiration per Evaluationpost-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026