Post Critical Illness Dysphagia in the Intensive Care Unit

Study Overview
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Brief Summary
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The aims of the study are to determine: 1) the prevalence of ICU acquired dysphagia, 2) identify risk factors for ICU Acquired dysphagia, and 3) consequences of ICU acquired dysphagia including: ICU mortality, hospital mortality, days of mechanical ventilation, ICU length of stay, hospital length of stay, post extubation aspiration pneumonia, and rate of percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion, and/or total parenteral nutrition (TPN) and/or Dobhoff feeds.

Detailed Description
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The RC will collect daily data on the use of advance life support, need for mechanical ventilation and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and a videofluroscopic swallowing study (VFSS) performed by a registered speech-language pathologist (SLP). A VFSS is a videotaped or digitized dynamic fluoroscopic image that focuses on the oral, pharyngeal, laryngeal and upper esophageal swallow physiology. Patients will then be followed as two cohorts 1) patients that have dysphagia (or abnormal test) based on the VFSS, and 2) patients who have normal VFSS. We will then prospectively follow these two groups of patients during hospital stay censored at 30 days.

Official Title
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Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study

Conditions
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Dysphagia

Intervention / Treatment
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* Diagnostic Test: VideoFlurosocopy Swallow Study
* Diagnostic Test: Water Sip Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years of age and older) Received mechanically ventilated for > 24 hours Have been extubated for >24 hours Hemodynamically stable (i.e. not requiring active resuscitation or vasoactive agents) Able to participate in VFSS - with n the first 7 days after successful extubation. (+/- 2 days) Exclusion Criteria: Gastrostomy tube or a Gastro-jejunostomy tubes Current contraindication to oral feeding (eg. recent gastrointestinal surgeries as indicated by their surgeons) Being actively palliated Tracheostomy Neuromuscular condition associated with dysphagia: (e.g., amyotrophic lateral sclerosis, myasthenia gravis) Pre-existing history of dysphagia Ongoing respiratory support (defined as requiring ≥ 50% oxygen, bi-level positive airway pressure, or high flow nasal cannula) for 7 days or more after extubation. Caring physician declined

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single center prospective pilot study of post critical illness dysphagia .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VFSS and Water Sip Test<br>Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS) | Diagnostic Test: VideoFlurosocopy Swallow Study<br>* VFSS is a radiological examination that can identify the presence, nature and severity of any abnormalities in oropharyngeal, laryngeal and upper esophageal swallow physiology. The VFSS will be administered via a standardized protocol by a registered speech-language pathologist (SLP). During the VFSS, the patient is seated upright and swallows a variety of consistencies (eg. liquids, semisolids and solids) and volumes of barium-coated foods. A dynamic fluoroscopic image will be digitally captured and recorded.<br>* Other names: VFSS;Diagnostic Test: Water Sip Test<br>* The steps of the water sip test include; 1. The patient will be given 5 ml of water, and if tolerated 20 ml followed by 50 ml of water (thin fluid) and the patient is assessed for cough/chocking during or after swallowing, wet or weak cough after swallowing. 2. The patient is asked to produce sustained vowel /a/ before and after swallowing of water and voice change after swallowing will be observed and recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia | Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision. | Hospital Discharge or 30 days post VFSS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspiration | During drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician | Hospital Discharge or 30 days post VFSS | 
| Pneumonia | Define as new pneumonia after extubation as noted in clinical chart | Hospital Discharge or 30 days post VFSS | 
| Length of Stay | ICU and Hospital | Hospital Discharge or 30 days post VFSS | 
| PEG tube insertion or need for TPF or Dobhoff feeds | • Percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion or need for TPF or Dobhoff feeds | Hospital Discharge or 30 days post VFSS | 
| Mortality | In ICU or In Hospital | Hospital Discharge or 30 days post VFSS | 
| Reintubation | Defined as reintubation within 30 days of original extubation during initial hospital admission. Reasons for reintubation will be recorded. | Hospital Discharge or 30 days post VFSS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mehanical Ventilation, Dysphagia, VideoFluroscopy