What is this study trying to find out about swallowing problems after breathing machine use?

This study is evaluating swallowing difficulties that can happen after very sick patients use a breathing machine with a tube in their throat. It aims to understand how often these problems occur, why they happen, and the best ways to detect them. The University of Colorado, Denver leads this research to improve care for affected patients.

Who may be eligible for this dysphagia clinical trial?

Adults aged 18 years or older who were admitted to an ICU and required mechanical ventilation with an endotracheal tube for more than 48 hours may be eligible. People with prior swallowing problems, neuromuscular disorders, or certain other health conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this dysphagia clinical trial?

Study-related care, including all tests and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05108896

Study of Swallowing Problems After Breathing Machine Use in ICU Patients Assessing Aspiration Risk Using Swallow Tests and Endoscopic Exams

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

855

Participants Needed

Research Sites

N/A

Total Duration

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

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Bedside 3-Screenings Protocol plus Tracheal Ultrasound	Standard Endoscopic Swallow Assessment (FEES)
What it is	A combined bedside screening protocol (decision-tree exam using voice quality, Yale Swallow Test, 3-ounce Water Swallow Test, and TOR-BSST) plus ultrasound imaging of the trachea to predict aspiration risk after prolonged intubation.	A flexible fiberoptic endoscope is passed transnasally to directly visualize swallowing, allowing detection of aspiration or dysphagia. FEES provides real-time video assessment of airway protection and food or liquid entry into the airway.
Role in the study	Investigational diagnostic strategy tested for its accuracy in predicting aspiration risk in ICU survivors, prior to FEES as the reference standard.	Reference diagnostic standard; results from FEES are used as the benchmark to judge the performance of new screening methods.
Primary use	Early detection of aspiration risk at the bedside in patients recovering from respiratory failure after mechanical ventilation, aiming for a rapid and less-invasive initial screen.	Standard of care diagnostic procedure to directly identify aspiration and swallowing safety in high-risk patients after extubation.
How it is performed	A nurse or clinician conducts a voice quality check, performs multiple water swallow tests and the TOR-BSST, then uses tracheal ultrasound for anatomical measurements—all at the bedside before oral feeding resumes.	A clinician passes a thin flexible endoscope through the nose, allowing direct video observation of the throat and larynx while the patient swallows test boluses. Videos are assessed by multiple raters.
Evidence status	Undergoing clinical validation in this population; accuracy compared with FEES is still being established.	Supported by multiple studies as a sensitive and specific method for detecting aspiration; regarded as a benchmark test for clinical research and practice.
Important limitations	Novel protocol; true diagnostic accuracy, false-negative and false-positive rates compared with FEES still require full validation. Rater experience, patient cooperation, and ultrasound access may influence results.	Requires specialized equipment and trained clinicians; may be uncomfortable or not feasible for all patients; visual field can be limited by secretions or anatomy. Cannot fully detect subclinical aspiration.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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

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

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