Post Critical Illness Dysphagia in the Intensive Care Unit

Dysphagia Clinical Trial

— DysphagiaICU  

Official title:

Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04349462
• Other study ID #: 7298
• Status: Suspended
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: St. Joseph's Healthcare Hamilton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Deglutition Disorders
• Dysphagia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

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