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

Trial Summary

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 data supports the effectiveness of the treatment 3-Screenings Protocol, FEES, Tracheal Ultrasound for aspiration in respiratory failure survivors?

Research shows that using ultrasound to observe swallowing can help improve safe eating and drinking in people with swallowing problems, reducing the risk of choking and pneumonia. This suggests that tracheal ultrasound, as part of the treatment, may be effective in assessing and managing swallowing issues in respiratory failure survivors. ^{1 2 3 4 5}

Is the Swallowing Assessment Protocol safe for humans?

Research shows that using ultrasound for swallowing assessments is generally safe, as no cases of pneumonia or suffocation were reported during studies. This suggests that the protocol is safe for humans. ^{1 2 4 5 6}

How does the swallowing assessment protocol treatment differ from other treatments for aspiration in respiratory failure survivors?

The swallowing assessment protocol is unique because it focuses on bedside evaluations to detect aspiration risk in respiratory failure survivors, aiming to reduce complications and allow for timely oral nutrition. This approach is less invasive compared to other methods like fiberoptic endoscopic evaluation of swallowing (FEES), which requires specialized equipment and expertise. ^{2 4 7 8 9}

What is the purpose of this trial?

The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.

Research Team

Marc Moss, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Japan 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Can bedside assessment reliably exclude aspiration following acute stroke? [2019]

3. England pubmed.ncbi.nlm.nih.gov

Assessing Swallowing Dysfunction Aggravation in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonic Measurements With Swallowing Movement Parameters. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Swallowing and Aspiration Risk: A Critical Review of Non Instrumental Bedside Screening Tests. [2023]

5. Switzerland 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. [2020]

6. Switzerland 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. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Early assessment of aspiration risk in acute stroke by fiberoptic endoscopy in critically ill patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The accuracy of the bedside swallowing evaluation for detecting aspiration in survivors of acute respiratory failure. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

FEES protocol derived estimates of sensitivity: aspiration in dysphagic patients. [2021]