Post Extubation Dysphagia

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.

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Key information

Conditions

Severity of Aspiration in Post-extubated Subjects Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of Swallowing

Other

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

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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

The Effect on Time After Extubation on Aspiration Risk

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: May 8, 2013
Registry last updated: Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed