Post Extubation Dysphagia

October 31, 2016 updated by: University of Wisconsin, Madison

The Effect on Time After Extubation on Aspiration Risk

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Intubated inpatients 18 years and older at the University of Wisconsin Hospital Trauma and Life Support Center.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-Extubation Subjects
Other: Evaluation of Swallowing
Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post-extubation at 2-4 hours and possibly 24-26 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Stevie Marvin, MS, Univeristy of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-0407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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