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

November 14, 2023 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient under mechanical ventilation for at least 7 days
Other: Ultrasound
performed within 3 hours prior to extubation
Other: nasofibroscopie
performed within 24 to 36 hours after extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of swallowing disorders
Time Frame: Within 24 to 36 hours of extubation
assessed by the Penetration-Aspiration Scale (PAS)
Within 24 to 36 hours of extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINEDA APPARA 2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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