Development of a new tool for assessing swallowing in patients with severe brain injuries
The Development and Validation of the SWADOC Tool: A Study Protocol for a Multicentric Prospective Cohort Study
This study is testing a new tool to help doctors better understand swallowing problems in patients with severe brain injuries who may not be fully aware of their surroundings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Liege Academic / other |
| Locations | 8 sites (Ottignies-Louvain-la-Neuve, Brabant Wallon and 7 other locations) |
| Trial ID | NCT04706689 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate the SWADOC tool, designed specifically for assessing swallowing disorders in patients with disorders of consciousness (DOC) following severe brain injuries. The study will involve a multicentric prospective cohort of 104 patients who will be evaluated three times over two consecutive days using the SWADOC tool. The researchers will analyze the relationship between the patients' level of consciousness and their scores on the SWADOC assessment. This tool is intended to improve the evaluation and therapy of dysphagia in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have experienced a coma due to severe acquired brain injury and have a diagnosis of disorders of consciousness.
Not a fit: Patients who have pre-existing neurological or otorhinolaryngological conditions affecting swallowing prior to their brain injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly enhance the assessment and management of swallowing disorders in patients with severe brain injuries, leading to better patient outcomes.
How similar studies have performed: While the SWADOC tool is a novel approach, similar studies have shown the importance of tailored assessment tools for improving patient care in dysphagia and disorders of consciousness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Age above 18-year-old * Perfect knowledge of French language before the injury * Previous event of coma phase caused by a severe acquired brain injury * Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress) * No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury * Minimum of 28 days since the acquired brain injury at inclusion * Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs * Informed consent from legal representative of the patient * Affiliated patient or beneficiary of a health insurance plan (for French participants only).
Where this trial is running
Ottignies-Louvain-la-Neuve, Brabant Wallon and 7 other locations
- Centre Hospitalier Neurologique William Lennox (UCL) — Ottignies-Louvain-la-Neuve, Brabant Wallon, Belgium (Recruiting)
- Centre neurologique et de réadaptation fonctionnelle de Fraiture-en-Condroz — Fraiture, Belgium (Recruiting)
- Centre de Traumatologie et de Réadaptation de Jette (Erasme, ULB) — Jette, Belgium (Recruiting)
- Centre du Cerveau², University Hospital of Liège — Liège, Belgium (Recruiting)
- Cliniques de Soins Spécialisés Valdor-Pèrî — Liège, Belgium (Recruiting)
- Fontfroide functional re-education centre — Montpellier, France (Recruiting)
- CHU Nîmes — Nîmes, France (Not_yet_recruiting)
- Uzès hospital — Uzès, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Evelyne Mélotte, M.D.
- Email: evelyne.melotte@chuliege.be
- Phone: 00323663915
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.