Swallowing Assessment Protocols for Aspiration in Respiratory Failure Survivors

Recruiting at 4 trial locations

Overseen By Jeff McKeehan, RN,MSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Dysphagia, Neuromuscular disorder, Tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

855 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand swallowing issues that could develop in patients who have been critically ill and required mechanical ventilation. Researchers are testing various methods to assess swallowing, including a tracheal ultrasound (a scan of the windpipe), three screening tests (3-Screenings Protocol), and a fiberoptic endoscopic exam (a camera check of swallowing, also known as FEES). The trial seeks participants who were in an ICU and used a breathing tube for more than two days but have no history of swallowing problems. As an unphased trial, it offers a unique opportunity to contribute to research that could improve care for future patients with similar experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these swallowing assessment protocols are safe for respiratory failure survivors?

Research has shown that the 3-Screenings Protocol, which includes the 3-ounce water swallow test and the TOR-BSST, is generally safe for patients. The 3-ounce water swallow test, used in many studies, effectively identifies swallowing problems without causing harm.

Studies have demonstrated that FEES (Fiberoptic Endoscopic Evaluation of Swallowing) reliably checks swallowing. While mostly safe, some patients might face a slightly higher risk of conditions like pneumonia if food or liquid enters the airway during the test. However, the procedure itself remains effective and safe for assessing swallowing issues.

Tracheal ultrasound is another safe and non-invasive method. It has been used to monitor patients with breathing problems and guides treatments without major safety concerns reported in previous studies.

Overall, these assessments are well-tolerated, with minimal side effects, making them relatively safe options for evaluating swallowing issues in patients recovering from respiratory failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to assess swallowing difficulties in patients recovering from respiratory failure. Unlike traditional methods that might rely solely on clinical observation or subjective assessments, this trial uses a combination of advanced techniques like tracheal ultrasound and fiberoptic endoscopic examination of swallowing (FEES). These methods can provide real-time, detailed insights into a patient’s swallowing function, potentially allowing for more accurate diagnoses and tailored interventions. By integrating these screenings, the trial aims to enhance the early detection of aspiration risk, which could lead to better outcomes and faster recovery for patients.

What evidence suggests that these swallowing assessment protocols are effective for aspiration in respiratory failure survivors?

In this trial, all participants will receive a tracheal ultrasound, a newer method using sound waves to examine the throat. This technique has shown promise in identifying swallowing issues, helping ensure safer eating and drinking for those with such problems and reducing the risk of aspiration. Additionally, the trial employs the 3-Screenings Protocol, which includes tests like the 3-ounce water swallow test and the TOR-BSST, to effectively identify swallowing issues. The 3-ounce water swallow test predicts who might accidentally inhale food or liquid into their lungs, known as aspiration. The TOR-BSST highlights a higher risk of swallowing problems if any part of the test is not passed. Participants will also undergo FEES (fiberoptic endoscopic evaluation of swallowing), a respected method known for accurately detecting aspiration in patients with sudden breathing problems. ^{1 2 3 6 7}

Who Is on the Research Team?

Marc Moss, MD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults who've been in the ICU and on a ventilator for over 48 hours. It's not suitable for those with uncontrolled bleeding, persistent delirium after extubation, neuromuscular disorders, chronic tracheostomy before ICU admission, head and neck cancer or surgery history, under 18s, prior swallowing issues or aspiration history.

Inclusion Criteria

I have been on a breathing machine with a tube for more than 2 days.

I have been admitted to an intensive care unit.

Exclusion Criteria

I have a muscle or nerve disorder affecting my brain, spinal cord, or nerves.

Inability to obtain informed consent from patient or an appropriate surrogate

You have been breathing without a tube for more than 72 hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Extubation Assessment

Participants receive a tracheal ultrasound within 72 hours prior to extubation and collection of demographic and hospital clinical information

Up to 3 days

Post-Extubation Assessment

Administration of 3 screening tests addressing swallowing function within 24 hours post-extubation and a fiberoptic endoscopic examination of swallowing (FEES) exam

1 day

Follow-up

Participants are monitored for post-extubation dysphagia and aspiration from extubation day 1 through hospital discharge

Up to 28 days

What Are the Treatments Tested in This Trial?

Interventions

• 3-Screenings Protocol
• FEES
• Tracheal Ultrasound

Trial Overview

The study tests three methods to understand swallowing problems post-acute respiratory failure: FEES (a type of swallow test), a protocol involving three screenings for swallowing safety, and tracheal ultrasound to assess airway management.

How Is the Trial Designed?

Group I: Aspiration in Acute Respiratory Failure Survivors Experimental Treatment 3 Interventions

All participants will receive a tracheal ultrasound within 72 hours prior to extubation, collection of demographic and hospital clinical information, administration of 3 screening tests (study defined algorithm test, 3-ounce water swallow test, TOR-BSST) addressing swallowing function within 24 hours post-extubation, and a fiberoptic endoscopic examination of swallowing (FEES) exam.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

Fiberoptic endoscopic evaluation of swallowing (FEES) using the penetration-aspiration scale (PAS) effectively assesses aspiration risk in acute stroke patients, with 58.2% classified as high risk, leading to significant complications like aspiration pneumonia and increased ICU stay.

The PAS score is a reliable predictor of aspiration pneumonia and mortality, showing high sensitivity (80% for pneumonia and 88.46% for mortality) and specificity, making it a valuable tool for early assessment in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early assessment of aspiration risk in acute stroke by fiberoptic endoscopy in critically ill patients. Elsyaad, MSA., Fayed, AM., Megahed, MMAS., et al.[2022]

A review of 12 studies on bedside screening tools for dysphagia and aspiration risk in acute stroke patients revealed that most existing methods have poor predictive value, making it difficult for clinicians to confidently recommend dietary changes.

There is a critical need for a standardized, practical, and cost-effective screening tool that can be easily used by various hospital staff to improve the early detection and management of swallowing issues in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallowing and Aspiration Risk: A Critical Review of Non Instrumental Bedside Screening Tests. Virvidaki, IE., Nasios, G., Kosmidou, M., et al.[2023]

A bedside swallowing assessment conducted on 94 stroke patients showed low sensitivity (47%) for detecting aspiration, meaning it often missed cases where patients were aspirating, despite having a higher specificity (86%).

The study suggests that while bedside assessments are not reliable for screening aspiration in acute stroke patients, certain indicators like a weak voluntary cough and altered consciousness could improve prediction accuracy, achieving a sensitivity of 75% and a negative predictive value of 91%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can bedside assessment reliably exclude aspiration following acute stroke? Smithard, DG., O'Neill, PA., Park, C., et al.[2019]

Ultrasonography has good diagnostic accuracy for detecting aspiration in patients with dysphagia, with a pooled sensitivity of 82% and specificity of 87% based on five studies.

While ultrasound is a promising non-invasive screening tool for aspiration, its effectiveness in detecting pharyngeal residue is lower, with sensitivity at 62% and specificity at 67%, and the overall certainty of evidence is low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of ultrasound examination in detecting aspiration and pharyngeal residue in patients with dysphagia: A systematic review and meta-analysis. Miura, Y., Tamai, N., Kitamura, A., et al.[2021]

In a randomized controlled trial with 46 participants, using ultrasound examinations to guide swallowing care significantly reduced the frequency of aspiration and pharyngeal residue compared to standard care.

The intervention group showed a median reduction of 31% in aspiration and residue, while the control group only had an 11% reduction, highlighting the potential effectiveness of ultrasound-guided swallowing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial to Investigate the Effectiveness of the Prevention of Aspiration Pneumonia Using Recommendations for Swallowing Care Guided by Ultrasound Examination. Miura, Y., Nakagami, G., Yabunaka, K., et al.[2020]

The study involved 12 adult patients aged 44-91 who had experienced choking, and it found that ultrasound-based swallowing care significantly improved safe food intake levels without any incidents of pneumonia or suffocation during the intervention.

While the ultrasound observation-based training enhanced safe oral intake, it did not lead to significant improvements in swallowing muscle strength, indicating that while the method is safe and effective for food intake, additional strategies may be needed to strengthen swallowing muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Swallowing Care on Safe Oral Intake Using Ultrasound-Based Observation of Residues in the Epiglottis Valley: A Pragmatic, Quasi-Experimental Study. Yoshida, M., Miura, Y., Okada, S., et al.[2020]

Ultrasonic measurements of swallowing movement parameters can effectively identify and assess the severity of swallowing dysfunction in patients with chronic obstructive pulmonary disease (COPD), based on a study of 220 patients (120 with dysfunction and 100 without).

Key parameters such as hyoid muscle thickness and geniohyoid muscle movement distance were found to be lower in COPD patients with swallowing issues, indicating a strong correlation between these measurements and the severity of swallowing dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Swallowing Dysfunction Aggravation in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonic Measurements With Swallowing Movement Parameters. Huang, Y., Zhong, H., Xu, Z., et al.[2023]

In a study of 45 acute respiratory failure survivors, the bedside swallowing evaluation (BSE) and its components, particularly the 3-ounce water swallowing test (3-WST), showed variable accuracy in detecting aspiration, with a sensitivity of 77% and specificity of 65%.

The findings suggest that while the BSE can help identify aspiration risks, further research is needed to establish the most effective noninvasive tests for this population, as the accuracy of current methods varies significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. Lynch, YT., Clark, BJ., Macht, M., et al.[2018]

A study involving 84 patients with oropharyngeal dysphagia found that using a limited number of swallow trials (three or four) during fiberoptic endoscopic evaluation of swallowing (FEES) can significantly underestimate the risk of aspiration.

The research highlighted that different patient populations (oncology vs. neurology) require varying numbers of swallow trials to accurately assess aspiration risk, with oncology patients needing fewer trials than neurology patients for thin liquids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FEES protocol derived estimates of sensitivity: aspiration in dysphagic patients. Baijens, LW., Speyer, R., Pilz, W., et al.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5481997/

The Accuracy of the Bedside Swallowing Evaluation for ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/18058175/

Clinical utility of the 3-ounce water swallow test

A total of 1151 (38.4%) passed and 1849 (61.6%) failed the 3-ounce water swallow test. Sensitivity of the 3-ounce water swallow test for predicting aspiration ...

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ahajournals.org

ahajournals.org/doi/10.1161/strokeaha.107.510370

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A pass/fail response was assigned to each item so that failure on any item constitutes a positive screen result and therefore an increased risk ...

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rps.researchcommons.org

rps.researchcommons.org/cgi/viewcontent.cgi?article=2254&context=journal

Principles and Practices of Selecting Screening Tools for ...

The third step involves swallowing 100 ml of water twice within 1 min. Failure at any step leads to a recommendation of nasogastric tube ...

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researchgate.net

researchgate.net/publication/5790401_Clinical_Utility_of_the_3-ounce_Water_Swallow_Test

Clinical Utility of the 3-ounce Water Swallow Test

... 3-ounce water swallow test is not indicative of swallowing failure. ... Results Of all the 60 patients, 35 (58.3%) failed the TOR‐BSST‐TR ...

6.

ejo.springeropen.com

ejo.springeropen.com/articles/10.1186/s43163-024-00729-8

The efficacy of 3-ounce water swallow test as a screening tool ...

... 3-oz water swallow test yielded 39 positive cases (i.e., failed) and 51 negatives (i.e., passed the test), with no statistically significant ...

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frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1375408/pdf

Perspective on dysphagia screening, assessment methods ...

The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. J. Criti. Care 39, 143 ...