Post Critical Illness Dysphagia in the Intensive Care Unit

Not Applicable

Suspended

• Conditions: Dysphagia
• Interventions: Diagnostic Test: VideoFlurosocopy Swallow Study; Diagnostic Test: Water Sip Test

• Registration Number: NCT04349462
• Lead Sponsor: St. Joseph's Healthcare Hamilton

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.

Study Timeline

• Study Start: 2019-09-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 300

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VFSS and Water Sip Test	VideoFlurosocopy Swallow Study	Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS)
VFSS and Water Sip Test	Water Sip Test	Enrolled patients will undergo a water sip test and Videofluroscopy Swallow Test (VFSS)

Primary Outcome Measures

Name	Time	Method
Dysphagia	Hospital Discharge or 30 days post VFSS	Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.

Secondary Outcome Measures

Name	Time	Method
PEG tube insertion or need for TPF or Dobhoff feeds	Hospital Discharge or 30 days post VFSS	• Percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion or need for TPF or Dobhoff feeds
Aspiration	Hospital Discharge or 30 days post VFSS	During drinking, eating, taking oral medication or other health professional-as documented in the clinical note by the treating physician
Pneumonia	Hospital Discharge or 30 days post VFSS	Define as new pneumonia after extubation as noted in clinical chart
Length of Stay	Hospital Discharge or 30 days post VFSS	ICU and Hospital
Mortality	Hospital Discharge or 30 days post VFSS	In ICU or In Hospital
Reintubation	Hospital Discharge or 30 days post VFSS	Defined as reintubation within 30 days of original extubation during initial hospital admission. Reasons for reintubation will be recorded.

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada