search
Back to results

Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU (EIDAR)

Primary Purpose

Patient Under Mechanical Ventilation

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasound
nasofibroscopie
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patient Under Mechanical Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient: Major On mechanical ventilation for at least 7 days Affiliated to national health insurance Exclusion Criteria: Patient: Under legal protection (curatorship, guardianship, safeguard of justice) Pregnant, parturient or breastfeeding woman Refusal to participate by the patient or their proxy (or an immediate family member) Cognitive disorders incompatible with the understanding of instructions Previously diagnosed swallowing disorders With a neurological condition at the origin of the SD (stroke, ALS...) Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy) presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit With one or more contraindications to performing NF: Anatomical features not compatible with NF: mainly deviation of the nasal septum. Risk of significant otorhinolaryngological bleeding

Sites / Locations

  • Chu Dijon Bourgogne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patient under mechanical ventilation for at least 7 days

Arm Description

Outcomes

Primary Outcome Measures

rate of swallowing disorders
assessed by the Penetration-Aspiration Scale (PAS)

Secondary Outcome Measures

Full Information

First Posted
June 19, 2023
Last Updated
September 8, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT05922085
Brief Title
Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
Acronym
EIDAR
Official Title
Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Swallowing disorders (SD) are particularly common after extubation in the ICU and may be associated with an increased risk of lung disease, increased length of hospital stay, and a higher risk of early reintubation. In contrast, early detection of SDs has been shown to be associated with a decrease in these complications. Thus, there is a need for rapid and reliable assessment of SDs in ICU patients before the withdrawal of mechanical ventilation. Videofluoroscopy (VFS) and nasofibroscopy (NF) are the gold standard examinations for diagnosing SD. However, these two examinations are not feasible in intubated patients. In this context, ultrasound appears to be a promising alternative to identify patients at risk of SD after extubation. This examination can be performed at the intubated patient's bedside and can be used evaluate the mobility of the structures involved in swallowing. Many studies have already shown the interest of ultrasound in the evaluation of SD but none has focused on intubated patients under respiratory assistance. The objective of the present study is to evaluate the value of ultrasound in identifying patients at risk of presenting SD after extubation. This monocentric study will take place in the Intensive Care Unit (ICU) of the Dijon University Hospital. The duration of participation in this research will be equal to the length of stay in the ICU. During their stay, patients will undergo ultrasound and nasofibroscopy. Information on the characteristics of the ICU stay will be collected at discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Under Mechanical Ventilation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient under mechanical ventilation for at least 7 days
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Description
performed within 3 hours prior to extubation
Intervention Type
Other
Intervention Name(s)
nasofibroscopie
Intervention Description
performed within 24 to 36 hours after extubation
Primary Outcome Measure Information:
Title
rate of swallowing disorders
Description
assessed by the Penetration-Aspiration Scale (PAS)
Time Frame
Within 24 to 36 hours of extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient: Major On mechanical ventilation for at least 7 days Affiliated to national health insurance Exclusion Criteria: Patient: Under legal protection (curatorship, guardianship, safeguard of justice) Pregnant, parturient or breastfeeding woman Refusal to participate by the patient or their proxy (or an immediate family member) Cognitive disorders incompatible with the understanding of instructions Previously diagnosed swallowing disorders With a neurological condition at the origin of the SD (stroke, ALS...) Treated for a lesion of the aerodigestive tract (by surgery, radiotherapy or radio-chemotherapy) presence of wounds or dressings on the areas to be evaluated that prevent ultrasound measurements Patient for whom a decision to limit or stop life support treatments has been taken collegially within the intensive care unit With one or more contraindications to performing NF: Anatomical features not compatible with NF: mainly deviation of the nasal septum. Risk of significant otorhinolaryngological bleeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose Arturo PINEDA MASEGOSA
Email
josearturo.pinedamasegosa@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Arturo PINEDA MASEGOSA
Email
josearturo.pinedamasegosa@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU

We'll reach out to this number within 24 hrs