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

St. Joseph's Healthcare Hamilton

Status: Suspended

Conditions: Dysphagia

Treatments: Diagnostic Test: Water Sip Test; Diagnostic Test: VideoFlurosocopy Swallow Study

Study type: Interventional

Funder types: Other

Identifiers

NCT04349462

7298

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

VFSS and Water Sip Test

Other group

Description:

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

Treatment:

Diagnostic Test: VideoFlurosocopy Swallow Study

Diagnostic Test: Water Sip Test