Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05108896

Aspiration in Acute Respiratory Failure Survivors to Study Swallowing Problems After Ventilator Use

Led by University of Colorado, Denver · Updated on 2024-10-08

855

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Institute of Nursing Research (NINR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying swallowing problems that may develop in very sick patients who need a machine to help them breathe. These patients require a tube placed in their throat, called an endotracheal tube, to allow the ventilator to push air into their lungs. After removing this tube, a condition called post-extubation dysphagia (PED) can occur, causing difficulty swallowing and risk of food or liquids entering the lungs, which may lead to lung problems. The study aims to better understand how often PED occurs, why it happens, and how to best detect it. Participants will receive several tests to evaluate swallowing function after extubation. These include a tracheal ultrasound within 72 hours before tube removal, demographic and clinical data collection, three different swallowing screening tests within 24 hours after extubation, and a fiberoptic endoscopic examination of swallowing (FEES). The FEES exam uses a small flexible camera passed through the nose to view swallowing and assess for dysphagia. During the study, researchers will monitor swallowing ability and the presence of aspiration from extubation day 1 through hospital discharge, expected within 28 days. They will also assess other outcomes like laryngeal swelling and duration of mechanical ventilation. Participants may have videos of their swallowing recorded for evaluation by specialists. The total involvement includes these assessments and data collection during the hospital stay after extubation.

CONDITIONS

Brief Title

Aspiration in Acute Respiratory Failure Survivors 2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admission to an ICU
  • Mechanical ventilation with an endotracheal tube for greater than 48 hours
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Likely persistent contraindications to enteral/oral nutrition
  • Pre-existing history of dysphagia or aspiration
  • Pre-existing or acute primary central or peripheral neuromuscular disorder
  • Presence of a chronic tracheostomy before ICU admission
  • Pre-existing head and neck cancer or surgery
  • Coagulopathy causing uncontrolled nasal or pharyngeal bleeding
  • Delirium lasting more than 96 hours after extubation
  • Extubated for more than 96 hours
  • Inability to provide informed consent
  • Age under 18 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 days around extubation

Participants undergo diagnostic tests including a tracheal ultrasound within 72 hours prior to extubation, three swallowing screening tests within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) to assess swallowing function and detect aspiration.

1 to 2 visits (in-person) around extubation

Long-term Monitoring

Duration - Up to 28 days

Participants are monitored from extubation day 1 through hospital discharge, expected to be within 28 days, for outcomes related to swallowing difficulties and aspiration.

Ongoing monitoring during hospital stay

Trial Site Locations

Total: 5 locations

1

Stanford Univerity

Stanford, California, United States, 94305

Actively Recruiting

2

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

Yale University

New Haven, Connecticut, United States, 06519

Actively Recruiting

4

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

5

Boston University

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

J

Jeff McKeehan, RN,MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Published Research Related To This Trial

Incidence and impact of dysphagia in patients receiving prolonged endotracheal intubation after cardiac surgery.

Jennifer Barker, Rosemary Martino, Beatrix Reichardt...

https://pubmed.ncbi.nlm.nih.gov/19399206

Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors.

Marc Moss, S David White, Heather Warner...

https://pubmed.ncbi.nlm.nih.gov/32721404

Relationship Between Laryngeal Sensation, Length of Intubation, and Aspiration in Patients with Acute Respiratory Failure.

James C Borders, Daniel Fink, Joseph E Levitt...

https://pubmed.ncbi.nlm.nih.gov/30694412

The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors.

Gintas P Krisciunas, Susan E Langmore, Stephanie Gomez-Taborda...

https://pubmed.ncbi.nlm.nih.gov/32804785