DysphagiaDysphagiaICUNCT04349462
Post Critical Illness Dysphagia in the Intensive Care Unit
A study testing VideoFlurosocopy Swallow Study and Water Sip Test in people with Dysphagia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- VideoFlurosocopy Swallow Study and Water Sip Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- VideoFlurosocopy Swallow Study, Water Sip Test
- Keywords
- Mehanical Ventilation, Dysphagia, VideoFluroscopy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoFlurosocopy Swallow StudyDiagnostic test
Also called VFSS
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.
Water Sip TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| VFSS and Water Sip Test | Other | Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS) Receives: Diagnostic Test: VideoFlurosocopy Swallow Study; Diagnostic Test: Water Sip Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia
Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.
Measured: Hospital Discharge or 30 days post VFSS
Secondary outcomes (6)
Aspiration
During drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician
Measured: Hospital Discharge or 30 days post VFSS
Pneumonia
Define as new pneumonia after extubation as noted in clinical chart
Measured: Hospital Discharge or 30 days post VFSS
Length of Stay
ICU and Hospital
Measured: 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
Measured: Hospital Discharge or 30 days post VFSS
Mortality
In ICU or In Hospital
Measured: 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.
Measured: Hospital Discharge or 30 days post VFSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start4 Sep 2019
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Recruitment has been suspended during COVID19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective pilot study of post critical illness dysphagia .
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Al-Hazzani, St. Joseph's Healthcare Hamilton
- Investigators
- Waleed Alhazzani, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349462
- Sponsor's protocol ID
- 7298
- Acronym
- DysphagiaICU
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04349462
- Acronym / sponsor ID
- DysphagiaICU / 7298
- Conditions
- Dysphagia
- Keywords
- Mehanical Ventilation, Dysphagia, VideoFluroscopy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been suspended during COVID19 Pandemic
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective pilot study of post critical illness dysphagia .
| Arm | Type | Receives |
|---|---|---|
| VFSS and Water Sip Test | Other | Diagnostic Test: VideoFlurosocopy Swallow Study, Diagnostic Test: Water Sip TestEnrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoFlurosocopy Swallow StudyAlso: VFSSVFSS 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. | Diagnostic test | VFSS and Water Sip Test |
| Water Sip TestThe 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. | Diagnostic test | VFSS and Water Sip Test |
Primary outcome
Dysphagia
Time frame: Hospital Discharge or 30 days post VFSS
Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.
6 secondary outcomes
Aspiration
Time frame: Hospital Discharge or 30 days post VFSS
Pneumonia
Time frame: Hospital Discharge or 30 days post VFSS
Length of Stay
Time frame: Hospital Discharge or 30 days post VFSS
PEG tube insertion or need for TPF or Dobhoff feeds
Time frame: Hospital Discharge or 30 days post VFSS
Mortality
Time frame: Hospital Discharge or 30 days post VFSS
Reintubation
Time frame: Hospital Discharge or 30 days post VFSS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed Alhazzani, MD, MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VideoFlurosocopy Swallow Study and Water Sip Test in people with Dysphagia, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia (time frame: Hospital Discharge or 30 days post VFSS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.