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OpenTrials
Completed

NCT Number: NCT06171165

Screening the Patient for Oral Intake: Applicability of the Yale Swallow Protocol in Patients Across Disease Categories

With 98 swallow screening tools already developed, dysphagia remains under-screened and undiagnosed. Even for patients at high risk of oropharyngeal dysphagia (i.e., hospitalized aged, post-stroke, Parkinson's disease, head and neck cancer, or those had ≥ 48 hours of endotracheal intubation), swallow screening is not systematically performed. Nurses, as front-line providers, are bombarded with patients' dysphagia. We witnessed patients' subsequent poor outcomes, including delayed oral intake, dependence on the feeding tube, increased pneumonia, prolonged hospital length of stay, and increased in-hospital.

Despite many calls for nurses to perform bedside screens for timely management, there is a lack of census on what tools to use (98 available, many claimed to be valid) and whether nurses are capable of safely performing these screens, especially when facing across-disease patients. Without a screening tool that is used universally across different diseases to assess whether patients can safely engage in oral intake, clinical healthcare professionals will face significant challenges in conducting the screening. Meanwhile, we found the common, shared items, i.e., consciousness, voice/speech, coughing, oral motor movements, and water drinking tests or swallowing trials, are included in most swallow screening tools, suggesting these items are essential basics for oral intake safely.

Therefore, instead of creating a new screening tool, the aim of this study is to extract the common, shared items among existing swallowing screening tools and assemble them into a swallow screening protocol that can be administered by nursing staff for triage whether inpatient populations are at risk of unsafe for oral intake. After conducting a systematic review and assessing the quality, we found the Yale Swallow Protocol was identified as a high-quality swallowing screening tool and was used for screening the risk of aspiration across diverse outpatients who were referred for further swallow assessment. However, whether the Yale Swallow Protocol can be implemented in acute care settings to screen for "oral intake" requires further warranted for its applicability. Therefore, this study aims to test the applicability (i.e., accuracy, responsiveness, time-spending, and safety) of the Yale Swallow Protocol when used to screen for 'oral intake,' with speech therapists' evaluations serving as the reference standard for inpatients across various disease categories.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University School of Nursing

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized patients with any of the following conditions: (a) head-and-neck cancer, (b) stroke, (c) Parkinson's disease, (d) post-extubated, and (e) aged above 65 years.
  • aged above 18 years.

Exclusion criteria

  • Patients will be excluded if they are (a) feeding-tube dependent (gastrostomy tube, nasogastric tube), (b) nil per os (NPO), or (c) with airborne-transmitted diseases (e.g., open tuberculosis or SARS).

Treatment and study plan

Yale Swallow Protocol

Diagnostic Test

All the participants will receive the two swallow screenings, i.e., Yale Swallow Protocol and Speech-language therapist, to classify the participants into either "try swallow" or "NPO" status.

Primary outcomes

  1. responsiveness

    Time frame: the time receiving the screenings

    floor effect or ceiling effect of Yale Swallow Protocol

  2. time-spending to execute Yale Swallow Protocol

    Time frame: the time receiving the screenings

    the mean and standard deviation

  3. safety

    Time frame: the time receiving the screenings

    whether any unanticipated adverse effect exists when executing Yale Swallow Protocol

Secondary outcomes

  1. responsiveness

    Time frame: the time receiving the screenings

    difficulty of Yale Swallow Protocol analyzed by Item Response Theory

  2. parsimony

    Time frame: the time receiving the screenings

    shorten the Yale Swallow Protocol by Item Response Theory

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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