Post Extubation Dysphagia

Completed

• Conditions: Severity of Aspiration in Post-extubated Subjects
• Interventions: Other: Evaluation of Swallowing

• Registration Number: NCT01849679
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-Extubation Subjects	Evaluation of Swallowing	-

Primary Outcome Measures

Name	Time	Method
Severity of Aspiration per Evaluation	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.

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States