Post Critical Illness Dysphagia in the Intensive Care Unit (DysphagiaICU)

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

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.

Study Overview

• Status: Suspended
• Conditions: Dysphagia
• Intervention / Treatment: Diagnostic test: VideoFlurosocopy Swallow Study; Diagnostic test: Water Sip Test

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults (18 years of age and older)
2. Received mechanically ventilated for > 24 hours
3. Have been extubated for >24 hours
4. Hemodynamically stable (i.e. not requiring active resuscitation or vasoactive agents)
5. Able to participate in VFSS - with n the first 7 days after successful extubation. (+/- 2 days)

Exclusion Criteria:

1. Gastrostomy tube or a Gastro-jejunostomy tubes
2. Current contraindication to oral feeding (eg. recent gastrointestinal surgeries as indicated by their surgeons)
3. Being actively palliated
4. Tracheostomy
5. Neuromuscular condition associated with dysphagia: (e.g., amyotrophic lateral sclerosis, myasthenia gravis)
6. Pre-existing history of dysphagia
7. 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.
8. Caring physician declined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: VFSS and Water Sip Test; Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS)

Diagnostic test: VideoFlurosocopy Swallow Study; 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.; Other Names: VFSS; Diagnostic test: Water Sip Test; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Waleed Alhazzani, MD, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2019
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (ACTUAL): April 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Mehanical Ventilation, Dysphagia, VideoFluroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Critical Illness
• Other Study ID Numbers: 7298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No