<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04428749</url>
  </required_header>
  <id_info>
    <org_study_id>69184</org_study_id>
    <nct_id>NCT04428749</nct_id>
  </id_info>
  <brief_title>Swallowing Difficulties in ICU Patients [Synkebesvær Hos Intensivpatienter]</brief_title>
  <acronym>ICU-Swallow</acronym>
  <official_title>Swallowing Difficulties in ICU Patients [Synkebesvær Hos Intensivpatienter]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospitalsenheden Vest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VIA University College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospitalsenheden Vest</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Swallow disorders or dysphagia related to mechanical ventilation affects between 1,300 and&#xD;
      2,000 patients in Danish intensive care units every year and increases aspiration, pneumonia&#xD;
      and risk of dying. In intensive care units, dysphagia may vary around the clock as fatigue&#xD;
      and fluctuating alertness play an important role for the patients' ability to swallow&#xD;
      effectively without aspiration to the airway. For this reason, ICU nurses must be able to&#xD;
      assess dysphagia in the ICU patient day and night, but guidelines are lacking.&#xD;
&#xD;
      One of the simplest and most sensitive methods is the Yale Swallow Protocol, however, this&#xD;
      protocol requires translation and validation before it can be implemented in Danish intensive&#xD;
      care units. This project aims to translate and validate the Yale Swallow Protocol for use in&#xD;
      Danish intensive care units. Furthermore, this project will explore nurses' perceptions and&#xD;
      management of dysphagia in the intensive care unit as well as feasibility and acceptability&#xD;
      of the Yale Swallow Protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Dysphagia caused by intubation and mechanical ventilation affects between 1.300&#xD;
      - 2.000 patients in Danish intensive care units (ICU's) every year. Dysphagia increases the&#xD;
      risk of aspiration, pneumonia, repeated mechanical ventilation and mortality. Despite this,&#xD;
      national and international guidelines for treating dysphagia in the ICU are lacking. In ICU&#xD;
      patients, dysphagia may vary around the clock as fatigue and cerebral status plays an&#xD;
      important role for the patients' ability to swallow effectively without aspiration. For this&#xD;
      reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night. This&#xD;
      will be an important addition to assessments made by occupational therapists usually only&#xD;
      available in the morning hours. However, for nurses to be able to assess dysphagia in the ICU&#xD;
      patients; development and validation of screening procedures are highly needed.&#xD;
&#xD;
      The development of a validated screening procedure to detect dysphagia in ICU patients will&#xD;
      furthermore pave the way for the developing and testing nursing interventions aiming at&#xD;
      improving dysphagia in ICU patients. This may reduce complications and improve quality of&#xD;
      life in patients.&#xD;
&#xD;
      Dysphagia related to mechanical ventilation and intensive care The swallow function depends&#xD;
      on a complicated interplay between more than 30 muscle pairs, cranial nerves and areas in the&#xD;
      cortex and the medulla oblongata. Causes for dysphagia in ICU patients are only partially&#xD;
      understood, however, the following factors have been suggested as significant: 1) Trauma to&#xD;
      the pharynx caused by intubation (placing a tube for mechanical ventilation in the airway),&#xD;
      2) Neuromyopathy resulting in muscular weakness, 3) Decreased level of consciousness caused&#xD;
      by medication, delirium or critical illness. Moreover, these factors may cause dysphagia in&#xD;
      ICU patients to vary from day to night.&#xD;
&#xD;
      Dysphagia is a serious complication to critical illness, potentially increasing mortality.&#xD;
      Despite this, research shows that nursing practice varies greatly. Nurses have different&#xD;
      views on what constitutes safe swallowing. Nonetheless, it often falls upon nurses to assess&#xD;
      patients swallowing function and determine whether to offer the patient something to eat and&#xD;
      drink or not. Thus, developing valid screening methods that can be used by ICU nurses may&#xD;
      improve patient safety and reduce complications due to dysphagia caused by intubation,&#xD;
      mechanical ventilation and critical illness.&#xD;
&#xD;
      Diagnosing dysphagia using FEES Dysphagia can be diagnosed using instrumental methods such as&#xD;
      the fiberoptic endoscopic evaluation of swallowing (FEES). This method is considered a gold&#xD;
      standard in assessing dysphagia. FEES may be performed bed-side by physicians or occupational&#xD;
      therapists by testing different foods and consistencies, but some patients find the FEES&#xD;
      disagreeable. A clinical examination by occupational therapists is another way to diagnose&#xD;
      dysphagia, however, silent aspiration without choking or coughing is difficult to detect in a&#xD;
      clinical examination.&#xD;
&#xD;
      (NOTE: In Denmark, the speech language therapist is usually an occupational therapist).&#xD;
&#xD;
      Screening for dysphagia Screening for dysphagia in general hospital populations is possible&#xD;
      by using different screening methods.&#xD;
&#xD;
      One of the most rigorously validated tests is the Yale Swallow Protocol (YSP). The YSP is a&#xD;
      three-step method consisting of an assessment of the patient's awareness, the patient's&#xD;
      ability to follow simple instructions and finally the patient's ability to drink 90 ml water&#xD;
      from a cup or by straw without stopping, choking or coughing. The YSP has high sensitivity of&#xD;
      0.96, thus effectively identifying patients who may safely begin oral feeding and drinking.&#xD;
      The specificity 0.5 indicates that patients who fail the YSP will need a specialized&#xD;
      assessment before eating and drinking is commenced. The clinical importance of this is that&#xD;
      nurses may employ the YSP at all hours to identify patients at risk, and thereby be able to&#xD;
      prevent aspiration detrimental to patient recovery. Moreover, patients not at risk can begin&#xD;
      oral feeding earlier, which may improve nutritional status and wellbeing in the patient.&#xD;
      However, dysphagia in ICU patients varies from other hospital patients because of intubation,&#xD;
      muscle weakness and alternating level of consciousness. Therefore it is necessary to validate&#xD;
      a translated version of the YSP on ICU patients to determine its predictive abilities. In&#xD;
      addition, skilled clinicians' uptake of a new screening method is a complex process.&#xD;
      Therefore, the feasibility and acceptability of the YSP in a Danish ICU needs to be explored&#xD;
      before the YSP can be recommended for implementation on a greater scale.&#xD;
&#xD;
      Research questions&#xD;
&#xD;
        1. Is systematic screening of dysphagia in ICU patients using the Yale Swallow protocol&#xD;
           feasible and acceptable to clinicians and patients?&#xD;
&#xD;
        2. Can the Yale Swallow Protocol, administered by ICU nurses bed side 24 hours a day,&#xD;
           identify dysphagia in ICU patients? What are the predictive abilities compared to FEES&#xD;
           (gold standard)?&#xD;
&#xD;
      Methods&#xD;
&#xD;
      STUDY 1&#xD;
&#xD;
      Design: Feasibility study. The aim of this study is to explore feasibility of implementing&#xD;
      and evaluating the YSP in a regional ICU and acceptability among clinicians and patients.&#xD;
      This includes exploring barriers and facilitators to screening ICU patients for dysphagia,&#xD;
      fidelity to the YSP and FEES methods and fidelity to recommendations for oral intake of food&#xD;
      and drinks based on the YSP and FEES.&#xD;
&#xD;
      The four-phased feasibility study will address feasibility of both the YSP and research&#xD;
      methods for study 2.&#xD;
&#xD;
      STUDY 2&#xD;
&#xD;
      Design: Prospective observational study, which will be adjusted based on the feasibility&#xD;
      study (study 1).&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      A. Screening 2-4 hours after extubation:&#xD;
&#xD;
      Ability to swallow is assessed by an ICU nurse using the YSP. If the YSP is negative, the&#xD;
      patient may start oral feeding and drinking. In case of a positive YSP, the screening may be&#xD;
      repeated within the next 24 hours provided the patient improves clinically. If YSP continues&#xD;
      to be positive the patient is referred to assessment by a speech language pathologist (SLP).&#xD;
&#xD;
      B. Screening within 24 hours:&#xD;
&#xD;
      To evaluate YSP against the FEES, the patient undergoes 1) YSP performed by an ICU nurse&#xD;
      followed by 2) FEES performed by an occupational therapist (until PAS&gt;6 (aspiration on any&#xD;
      food consistency on the Penetration Aspiration Scale). The occupational therapist will be&#xD;
      blinded to the assessment made by the ICU nurses. Patients will follow recommendations for&#xD;
      oral feeding and drinking as given by the occupational therapist.&#xD;
&#xD;
      Data:&#xD;
&#xD;
      For patients, the following data will be recorded: time and results of the initial YSP&#xD;
      screening 2-4 hours post extubation, recommendation for oral feeding and drinking, time and&#xD;
      results of the YSP and the FEES performed within 24 hours of extubation and recommendation&#xD;
      for oral feeding and drinking. In addition, sex, age, diagnosis, Simplified Acute Physiology&#xD;
      Score (SAPSIII) , Charlson Comorbidity Index, chronic obstructive pulmonary disease, length&#xD;
      of stay in hospital, length of stay in ICU, time on mechanical ventilation, new pneumonia&#xD;
      following extubation, FOIS (Functional Oral Intake Scale) and death within 30 days.&#xD;
&#xD;
      For clinicians performing the YSP and FEES, the following data will be recorded: age, sex,&#xD;
      profession, experience in years, and ICU experience in years.&#xD;
&#xD;
      Sample size: Given a prevalence of dysphagia among acute ICU patients of 18 %; a sensitivity&#xD;
      of YSP of 0.96 and a specificity of 0.5, then inclusion of 25 patients will be able to show a&#xD;
      negative likelihood ratio (LR-) of 0.1 [95 % CI 0,00; 5,74], which means that almost all&#xD;
      patients passing the YSP will be without dysphagia. Estimating the attrition rate to be 25 %,&#xD;
      35 patients will be included in the study.&#xD;
&#xD;
      Analysis: Screening by YSP and assessment by FEES with 24 hours will be tabulated in a 2x2&#xD;
      table, calculating the sensitivity, specificity, positive predictive value and negative&#xD;
      predictive value of YSP compared to FEES. Correlations between patient characteristics will&#xD;
      be calculated using Pearson and Spearman correlation statistics as appropriate.&#xD;
&#xD;
      Research ethics&#xD;
&#xD;
      All participants receive written and oral information about the purpose of the study and give&#xD;
      signed, informed consent. Relatives of patients are informed about the study. In case a&#xD;
      participant is affected adversely by participation, support will be offered by nurses and&#xD;
      physicians from the ICU.&#xD;
&#xD;
      The study is approved by the Health Research Committee of Region Central Jutland. The study&#xD;
      is registered with Danish Data protection Agency and data will be stored in REDCap hosted by&#xD;
      Aarhus University and Midt-X, a research data site hosted by the Central Denmark Region.&#xD;
&#xD;
      All data will be anonymized before shared or published; all data will be published.&#xD;
&#xD;
      Perspectives&#xD;
&#xD;
      If screening with the YSP can identify dysphagia in the critically ill patients, this will&#xD;
      allow oral feeding and drinking in many patients, leading to improved nutritional status and&#xD;
      increased patient satisfaction with no compromise of patient safety. Moreover, an effective&#xD;
      screening method for dysphagia may pave the way for developing nursing interventions to&#xD;
      prevent dysphagia from developing in the intensive care patient. In turn, this may reduce&#xD;
      complications, human suffering and costs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Aspiration on FEES</measure>
    <time_frame>Within 24 hours of extubation</time_frame>
    <description>Penetration aspiration scale (PAS scale) equal to or larger than 6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Yale Swallow protocol</measure>
    <time_frame>Within 30 minutes of the FEES</time_frame>
    <description>Passed or not passed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days after extubation</time_frame>
    <description>Dead or alive according to patient record</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Deglutition Disorders</condition>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Participants are screened using the Yale Swallow Protocol (YSP) 2-4 hours after extubation:&#xD;
Ability to swallow is assessed by an ICU nurse using the YSP. If the YSP is negative, the patient may start oral feeding and drinking. In case of a positive YSP, the screening may be repeated within the next 24 hours provided the patient improves clinically. If YSP continues to be positive the patient is referred to assessment by a speech language pathologist (SLP).&#xD;
Participants are screened within 24 hours:&#xD;
To evaluate YSP against the FEES, the patient undergoes 1) YSP performed by an ICU nurse followed by 2) FEES performed by a SLP (until PAS&gt;6 (aspiration on any food consistency on the Penetration Aspiration Scale (20)). The SLP will be blinded to the assessment made by the ICU nurses. Patients will follow recommendations for oral feeding and drinking as given by the SLP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Yale Swallow Protocol</intervention_name>
    <description>The YSP is a three-step method consisting of an assessment of the patient's awareness, the patient's ability to follow simple instructions and finally the patient's ability to drink 90 ml water from a cup or by straw without stopping, choking or coughing.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>FEES (fiberoptic endoscopic evaluation of swallowing)</intervention_name>
    <description>The FEES will be performed bedside by an experienced occupational therapists. The patient will be sitting upright in a chair and be given 1) 2 spoons of applesauce, 2) 2 spoons of water, 3) several sips of water, 4) 90 ml of water. All items colored blue.&#xD;
The FEES will use a single-use AMBU rhino-laryngo scope slim and the AMBU monitor. the examination will be terminated in case of aspiration below the vocal cords.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill adult patients from all clinical specialties who have been extubated after&#xD;
        mechanical ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  No prior records of dysphagia&#xD;
&#xD;
          -  Extubated after mechanical ventilation &gt; 24 hours.&#xD;
&#xD;
          -  Awake and alert with no sign of ICU delirium.&#xD;
&#xD;
          -  Must understand Danish, as all information available about the study is in Danish.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients who are unable to undergo the YSP&#xD;
&#xD;
          -  Patients who are unable to undergo the FEES&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne H Nielsen, Ph.d.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Hospital Holstebro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regionshospitalet Holstebro</name>
      <address>
        <city>Holstebro</city>
        <state>Region Midtjylland</state>
        <zip>7500</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospitalsenheden Vest</investigator_affiliation>
    <investigator_full_name>Anne Højager Nielsen</investigator_full_name>
    <investigator_title>Principal Investigator, MCN, PH.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04428749
org study id: 69184
nct id: NCT04428749
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Swallow disorders or dysphagia related to mechanical ventilation affects between 1,300 and
      2,000 patients in Danish intensive care units every year and increases aspiration, pneumonia
      and risk of dying. In intensive care units, dysphagia may vary around the clock as fatigue
      and fluctuating alertness play an important role for the patients' ability to swallow
      effectively without aspiration to the airway. For this reason, ICU nurses must be able to
      assess dysphagia in the ICU patient day and night, but guidelines are lacking.

      One of the simplest and most sensitive methods is the Yale Swallow Protocol, however, this
      protocol requires translation and validation before it can be implemented in Danish intensive
      care units. This project aims to translate and validate the Yale Swallow Protocol for use in
      Danish intensive care units. Furthermore, this project will explore nurses' perceptions and
      management of dysphagia in the intensive care unit as well as feasibility and acceptability
      of the Yale Swallow Protocol.
Introduction Dysphagia caused by intubation and mechanical ventilation affects between 1.300
      - 2.000 patients in Danish intensive care units (ICU's) every year. Dysphagia increases the
      risk of aspiration, pneumonia, repeated mechanical ventilation and mortality. Despite this,
      national and international guidelines for treating dysphagia in the ICU are lacking. In ICU
      patients, dysphagia may vary around the clock as fatigue and cerebral status plays an
      important role for the patients' ability to swallow effectively without aspiration. For this
      reason, ICU nurses must be able to assess dysphagia in the ICU patient day and night. This
      will be an important addition to assessments made by occupational therapists usually only
      available in the morning hours. However, for nurses to be able to assess dysphagia in the ICU
      patients; development and validation of screening procedures are highly needed.

      The development of a validated screening procedure to detect dysphagia in ICU patients will
      furthermore pave the way for the developing and testing nursing interventions aiming at
      improving dysphagia in ICU patients. This may reduce complications and improve quality of
      life in patients.

      Dysphagia related to mechanical ventilation and intensive care The swallow function depends
      on a complicated interplay between more than 30 muscle pairs, cranial nerves and areas in the
      cortex and the medulla oblongata. Causes for dysphagia in ICU patients are only partially
      understood, however, the following factors have been suggested as significant: 1) Trauma to
      the pharynx caused by intubation (placing a tube for mechanical ventilation in the airway),
      2) Neuromyopathy resulting in muscular weakness, 3) Decreased level of consciousness caused
      by medication, delirium or critical illness. Moreover, these factors may cause dysphagia in
      ICU patients to vary from day to night.

      Dysphagia is a serious complication to critical illness, potentially increasing mortality.
      Despite this, research shows that nursing practice varies greatly. Nurses have different
      views on what constitutes safe swallowing. Nonetheless, it often falls upon nurses to assess
      patients swallowing function and determine whether to offer the patient something to eat and
      drink or not. Thus, developing valid screening methods that can be used by ICU nurses may
      improve patient safety and reduce complications due to dysphagia caused by intubation,
      mechanical ventilation and critical illness.

      Diagnosing dysphagia using FEES Dysphagia can be diagnosed using instrumental methods such as
      the fiberoptic endoscopic evaluation of swallowing (FEES). This method is considered a gold
      standard in assessing dysphagia. FEES may be performed bed-side by physicians or occupational
      therapists by testing different foods and consistencies, but some patients find the FEES
      disagreeable. A clinical examination by occupational therapists is another way to diagnose
      dysphagia, however, silent aspiration without choking or coughing is difficult to detect in a
      clinical examination.

      (NOTE: In Denmark, the speech language therapist is usually an occupational therapist).

      Screening for dysphagia Screening for dysphagia in general hospital populations is possible
      by using different screening methods.

      One of the most rigorously validated tests is the Yale Swallow Protocol (YSP). The YSP is a
      three-step method consisting of an assessment of the patient's awareness, the patient's
      ability to follow simple instructions and finally the patient's ability to drink 90 ml water
      from a cup or by straw without stopping, choking or coughing. The YSP has high sensitivity of
      0.96, thus effectively identifying patients who may safely begin oral feeding and drinking.
      The specificity 0.5 indicates that patients who fail the YSP will need a specialized
      assessment before eating and drinking is commenced. The clinical importance of this is that
      nurses may employ the YSP at all hours to identify patients at risk, and thereby be able to
      prevent aspiration detrimental to patient recovery. Moreover, patients not at risk can begin
      oral feeding earlier, which may improve nutritional status and wellbeing in the patient.
      However, dysphagia in ICU patients varies from other hospital patients because of intubation,
      muscle weakness and alternating level of consciousness. Therefore it is necessary to validate
      a translated version of the YSP on ICU patients to determine its predictive abilities. In
      addition, skilled clinicians' uptake of a new screening method is a complex process.
      Therefore, the feasibility and acceptability of the YSP in a Danish ICU needs to be explored
      before the YSP can be recommended for implementation on a greater scale.

      Research questions

        1. Is systematic screening of dysphagia in ICU patients using the Yale Swallow protocol
           feasible and acceptable to clinicians and patients?

        2. Can the Yale Swallow Protocol, administered by ICU nurses bed side 24 hours a day,
           identify dysphagia in ICU patients? What are the predictive abilities compared to FEES
           (gold standard)?

      Methods

      STUDY 1

      Design: Feasibility study. The aim of this study is to explore feasibility of implementing
      and evaluating the YSP in a regional ICU and acceptability among clinicians and patients.
      This includes exploring barriers and facilitators to screening ICU patients for dysphagia,
      fidelity to the YSP and FEES methods and fidelity to recommendations for oral intake of food
      and drinks based on the YSP and FEES.

      The four-phased feasibility study will address feasibility of both the YSP and research
      methods for study 2.

      STUDY 2

      Design: Prospective observational study, which will be adjusted based on the feasibility
      study (study 1).

      Intervention:

      A. Screening 2-4 hours after extubation:

      Ability to swallow is assessed by an ICU nurse using the YSP. If the YSP is negative, the
      patient may start oral feeding and drinking. In case of a positive YSP, the screening may be
      repeated within the next 24 hours provided the patient improves clinically. If YSP continues
      to be positive the patient is referred to assessment by a speech language pathologist (SLP).

      B. Screening within 24 hours:

      To evaluate YSP against the FEES, the patient undergoes 1) YSP performed by an ICU nurse
      followed by 2) FEES performed by an occupational therapist (until PAS>6 (aspiration on any
      food consistency on the Penetration Aspiration Scale). The occupational therapist will be
      blinded to the assessment made by the ICU nurses. Patients will follow recommendations for
      oral feeding and drinking as given by the occupational therapist.

      Data:

      For patients, the following data will be recorded: time and results of the initial YSP
      screening 2-4 hours post extubation, recommendation for oral feeding and drinking, time and
      results of the YSP and the FEES performed within 24 hours of extubation and recommendation
      for oral feeding and drinking. In addition, sex, age, diagnosis, Simplified Acute Physiology
      Score (SAPSIII) , Charlson Comorbidity Index, chronic obstructive pulmonary disease, length
      of stay in hospital, length of stay in ICU, time on mechanical ventilation, new pneumonia
      following extubation, FOIS (Functional Oral Intake Scale) and death within 30 days.

      For clinicians performing the YSP and FEES, the following data will be recorded: age, sex,
      profession, experience in years, and ICU experience in years.

      Sample size: Given a prevalence of dysphagia among acute ICU patients of 18 %; a sensitivity
      of YSP of 0.96 and a specificity of 0.5, then inclusion of 25 patients will be able to show a
      negative likelihood ratio (LR-) of 0.1 [95 % CI 0,00; 5,74], which means that almost all
      patients passing the YSP will be without dysphagia. Estimating the attrition rate to be 25 %,
      35 patients will be included in the study.

      Analysis: Screening by YSP and assessment by FEES with 24 hours will be tabulated in a 2x2
      table, calculating the sensitivity, specificity, positive predictive value and negative
      predictive value of YSP compared to FEES. Correlations between patient characteristics will
      be calculated using Pearson and Spearman correlation statistics as appropriate.

      Research ethics

      All participants receive written and oral information about the purpose of the study and give
      signed, informed consent. Relatives of patients are informed about the study. In case a
      participant is affected adversely by participation, support will be offered by nurses and
      physicians from the ICU.

      The study is approved by the Health Research Committee of Region Central Jutland. The study
      is registered with Danish Data protection Agency and data will be stored in REDCap hosted by
      Aarhus University and Midt-X, a research data site hosted by the Central Denmark Region.

      All data will be anonymized before shared or published; all data will be published.

      Perspectives

      If screening with the YSP can identify dysphagia in the critically ill patients, this will
      allow oral feeding and drinking in many patients, leading to improved nutritional status and
      increased patient satisfaction with no compromise of patient safety. Moreover, an effective
      screening method for dysphagia may pave the way for developing nursing interventions to
      prevent dysphagia from developing in the intensive care patient. In turn, this may reduce
      complications, human suffering and costs.
observational model: Cohort
time perspective: Prospective
measure: Aspiration on FEES
time frame: Within 24 hours of extubation
description: Penetration aspiration scale (PAS scale) equal to or larger than 6
measure: Yale Swallow protocol
time frame: Within 30 minutes of the FEES
description: Passed or not passed
measure: Mortality
time frame: 30 days after extubation
description: Dead or alive according to patient record
arm group label: Study group
description: Participants are screened using the Yale Swallow Protocol (YSP) 2-4 hours after extubation:
Ability to swallow is assessed by an ICU nurse using the YSP. If the YSP is negative, the patient may start oral feeding and drinking. In case of a positive YSP, the screening may be repeated within the next 24 hours provided the patient improves clinically. If YSP continues to be positive the patient is referred to assessment by a speech language pathologist (SLP).
Participants are screened within 24 hours:
To evaluate YSP against the FEES, the patient undergoes 1) YSP performed by an ICU nurse followed by 2) FEES performed by a SLP (until PAS>6 (aspiration on any food consistency on the Penetration Aspiration Scale (20)). The SLP will be blinded to the assessment made by the ICU nurses. Patients will follow recommendations for oral feeding and drinking as given by the SLP.
intervention type: Diagnostic Test
intervention name: Yale Swallow Protocol
description: The YSP is a three-step method consisting of an assessment of the patient's awareness, the patient's ability to follow simple instructions and finally the patient's ability to drink 90 ml water from a cup or by straw without stopping, choking or coughing.
arm group label: Study group
intervention type: Diagnostic Test
intervention name: FEES (fiberoptic endoscopic evaluation of swallowing)
description: The FEES will be performed bedside by an experienced occupational therapists. The patient will be sitting upright in a chair and be given 1) 2 spoons of applesauce, 2) 2 spoons of water, 3) several sips of water, 4) 90 ml of water. All items colored blue.
The FEES will use a single-use AMBU rhino-laryngo scope slim and the AMBU monitor. the examination will be terminated in case of aspiration below the vocal cords.
arm group label: Study group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne H Nielsen, Ph.d.
role: Principal Investigator
affiliation: Regional Hospital Holstebro
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hospitalsenheden Vest
investigator full name: Anne Højager Nielsen
investigator title: Principal Investigator, MCN, PH.D.
mesh term: Deglutition Disorders
mesh term: Critical Illness
sharing ipd: Undecided