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Post Critical Illness Dysphagia in the Intensive Care Unit

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

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04349462
Acronym
DysphagiaICU
Enrollment
300
Registered
2020-04-16
Start date
2019-09-04
Completion date
2022-12-31
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia

Keywords

Mehanical Ventilation, Dysphagia, VideoFluroscopy

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.

Interventions

DIAGNOSTIC_TESTVideoFlurosocopy 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.

DIAGNOSTIC_TESTWater 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.

Sponsors

St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single center prospective pilot study of post critical illness dysphagia .

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DysphagiaHospital Discharge or 30 days post VFSSDefined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.

Secondary

MeasureTime frameDescription
PneumoniaHospital Discharge or 30 days post VFSSDefine as new pneumonia after extubation as noted in clinical chart
Length of StayHospital Discharge or 30 days post VFSSICU and Hospital
AspirationHospital Discharge or 30 days post VFSSDuring drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician
MortalityHospital Discharge or 30 days post VFSSIn ICU or In Hospital
ReintubationHospital Discharge or 30 days post VFSSDefined as reintubation within 30 days of original extubation during initial hospital admission. Reasons for reintubation will be recorded.
PEG tube insertion or need for TPF or Dobhoff feedsHospital Discharge or 30 days post VFSS• Percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion or need for TPF or Dobhoff feeds

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026