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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04349462
Other study ID # 7298
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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