Post Critical Illness Dysphagia in the Intensive Care Unit

NCT ID: NCT04349462

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-04
• Study Completion Date: 2022-12-31

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.

Conditions

Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

VFSS and Water Sip Test

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

Group Type: OTHER

VideoFlurosocopy Swallow Study

Intervention Type: 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.

Water Sip Test

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

VFSS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Waleed Al-Hazzani

Dr. Waleed Alhazzani

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waleed Alhazzani, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

7298

Identifier Type: -

Identifier Source: org_study_id