Clinical trial NCT04349462: Post Critical Illness Dysphagia in the Intensive Care Unit
Official title: Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dysphagia
Keywords: Mehanical Ventilation, Dysphagia, VideoFluroscopy
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center prospective pilot study of post critical illness dysphagia .
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dysphagia
timeFrame: Hospital Discharge or 30 days post VFSS
Secondary outcomes:
measure: Aspiration
timeFrame: Hospital Discharge or 30 days post VFSS
measure: Pneumonia
timeFrame: Hospital Discharge or 30 days post VFSS
measure: Length of Stay
timeFrame: Hospital Discharge or 30 days post VFSS
measure: PEG tube insertion or need for TPF or Dobhoff feeds
timeFrame: Hospital Discharge or 30 days post VFSS
measure: Mortality
timeFrame: Hospital Discharge or 30 days post VFSS
measure: Reintubation
timeFrame: Hospital Discharge or 30 days post VFSS
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Waleed Alhazzani, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: