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

Primary Purpose

Dysphagia

Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VideoFlurosocopy Swallow Study
Water Sip Test
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dysphagia focused on measuring Mehanical Ventilation, Dysphagia, VideoFluroscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

VFSS and Water Sip Test

Arm Description

Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS)

Outcomes

Primary Outcome Measures

Dysphagia
Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.

Secondary Outcome Measures

Aspiration
During drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician
Pneumonia
Define as new pneumonia after extubation as noted in clinical chart
Length of Stay
ICU and Hospital
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
Mortality
In ICU or In Hospital
Reintubation
Defined as reintubation within 30 days of original extubation during initial hospital admission. Reasons for reintubation will be recorded.

Full Information

First Posted
April 14, 2020
Last Updated
September 21, 2021
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04349462
Brief Title
Post Critical Illness Dysphagia in the Intensive Care Unit
Acronym
DysphagiaICU
Official Title
Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Suspended
Why Stopped
Recruitment has been suspended during COVID19 Pandemic
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Mehanical Ventilation, Dysphagia, VideoFluroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center prospective pilot study of post critical illness dysphagia .
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VFSS and Water Sip Test
Arm Type
Other
Arm Description
Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS)
Intervention Type
Diagnostic Test
Intervention Name(s)
VideoFlurosocopy Swallow Study
Other Intervention Name(s)
VFSS
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Water Sip Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dysphagia
Description
Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.
Time Frame
Hospital Discharge or 30 days post VFSS
Secondary Outcome Measure Information:
Title
Aspiration
Description
During drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician
Time Frame
Hospital Discharge or 30 days post VFSS
Title
Pneumonia
Description
Define as new pneumonia after extubation as noted in clinical chart
Time Frame
Hospital Discharge or 30 days post VFSS
Title
Length of Stay
Description
ICU and Hospital
Time Frame
Hospital Discharge or 30 days post VFSS
Title
PEG tube insertion or need for TPF or Dobhoff feeds
Description
• Percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion or need for TPF or Dobhoff feeds
Time Frame
Hospital Discharge or 30 days post VFSS
Title
Mortality
Description
In ICU or In Hospital
Time Frame
Hospital Discharge or 30 days post VFSS
Title
Reintubation
Description
Defined as reintubation within 30 days of original extubation during initial hospital admission. Reasons for reintubation will be recorded.
Time Frame
Hospital Discharge or 30 days post VFSS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed Alhazzani, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

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Post Critical Illness Dysphagia in the Intensive Care Unit

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