Post Critical Illness Dysphagia in the Intensive Care Unit

NCT04349462 | Suspended

• 1 other identifier: 7298
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia

Keywords

Mehanical Ventilation, Dysphagia, VideoFluroscopy

Outcome Measures

Primary Outcomes (1)

• Dysphagia

  Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.

  Hospital Discharge or 30 days post VFSS

Secondary Outcomes (6)

• Aspiration

  Hospital Discharge or 30 days post VFSS

• Pneumonia

  Hospital Discharge or 30 days post VFSS

• Length of Stay

  Hospital Discharge or 30 days post VFSS

• PEG tube insertion or need for TPF or Dobhoff feeds

  Hospital Discharge or 30 days post VFSS

• Mortality

  Hospital Discharge or 30 days post VFSS

Study Arms (1)

VFSS and Water Sip Test

OTHER

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

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

Interventions

VideoFlurosocopy Swallow Study DIAGNOSTIC_TEST

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.

Also known as: VFSS

VFSS and Water Sip Test

Water Sip Test DIAGNOSTIC_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.

VFSS and Water Sip Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Waleed Alhazzani, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Waleed Alhazzani

Model Details: Single center prospective pilot study of post critical illness dysphagia .

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: September 4, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CA (1)