NCT04349462

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: St. Joseph's Healthcare Hamilton · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	VideoFlurosocopy 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_TEST	Water 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.

Timeline

• Start date: 2019-09-04
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-04-16
• Last updated: 2021-09-27

Locations

1 site across 1 country: Canada