Patient Under Mechanical VentilationEIDARNCT05922085
Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
A study testing Ultrasound and nasofibroscopie in people with Patient Under Mechanical Ventilation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Under Mechanical Ventilation
- What is being tested?
- Ultrasound and nasofibroscopie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient:
- Major (≥18)
- On mechanical ventilation for at least 48 hours
- Affiliated to national health insurance
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon
Jose Arturo PINEDA MASEGOSA, josearturo.pinedamasegosa@chu-dijon.fr
About this study
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.
Read more
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.
- Conditions
- Patient Under Mechanical Ventilation
- Being tested
- Ultrasound, nasofibroscopie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
performed within 3 hours prior to extubation
nasofibroscopieOther
performed within 3 to 24 hours after extubation
| Study group | Role | What they receive |
|---|---|---|
| patient under mechanical ventilation for at least 48 hours | Experimental | Not described Receives: Other: Ultrasound; Other: nasofibroscopie |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of swallowing disorders
assessed by the Penetration-Aspiration Scale (PAS)
Measured: Within 3 to 24 hours of extubation
Secondary outcomes (11)
Presence (PAS score >2 for at least one of the food textures) or absence of SD evaluated by FEES
Measured: within 3 to 24 hours following extubation
Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES
Measured: Within 3 to 24 hours following extubation
Relationship between the presence or absence of SD and global muscle strength
Assessed by the MRC scale measurement before extubation
Measured: Within 3 hours prior to extubation
Relationship between the presence or absence of SD and muscle mass evaluated by ultrasound
Thickness of the right QF and cross-sectional area of the right RF muscle at rest
Measured: Within 3 hours prior to extubation
Relationship between the presence or absence of SD and cough strength before extubation
Evaluated by measuring the Peak Expiratory Flow (PEF) on the ventilator
Measured: Before extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist
Kappa for qualitative variables
Measured: Within 3 to 24 hours following extubation
Feasibility of the ultrasound examination
Proportion of ultrasounds performed (number of ultrasounds performed / number of eligible extubated patients) Identification of the reasons for not performing the ultrasound (e.g., physiotherapist unavailability, patient refusal) Proportion of uninterpretable ultrasounds (number of uninterpretable ultrasounds/number of ultrasounds performed) Identification of the reasons for uninterpretability of the ultrasound Mean time taken to perform the ultrasonographic assessment
Measured: Within 3 hours prior to extubation
Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES
Measured: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist
ICC for quantitative variables
Measured: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist
kappa for qualitative variables
Measured: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist
ICC for quantitative variables
Measured: Within 3 to 24 hours following extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start9 Nov 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Under Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922085
- Sponsor's protocol ID
- PINEDA APPARA 2022
- Acronym
- EIDAR
- Status last verified
- May 2026
- First submitted
- 19 Jun 2023
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pineda JA, Diaz C, Plasse C, Ruiz de la Fuente JM, Duvillard C, Bozorg-Grayeli A, Pennecot C, Labruyere M, Andreu P, Roudaut JB, Taha A, Morariu-Patrichi A, Jacquier M, Sow AK, Fournel I, Quenot JP. Use of ultrasound for early detection of ICU patients at risk of acquiring swallowing disorders: EIDAR, a prospective diagnostic study protocol. BMJ Open. 2026 Jun 11;16(6):e117547. doi: 10.1136/bmjopen-2026-117547.
PubMed 42276803
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound for Early Identification of Patients at Risk of Swallowing Disorders Acquired in the ICU
- ClinicalTrials.gov ID
- NCT05922085
- Acronym / sponsor ID
- EIDAR / PINEDA APPARA 2022
- Conditions
- Patient Under Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient under mechanical ventilation for at least 48 hours | Experimental | Other: Ultrasound, Other: nasofibroscopie |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major (≥18)
- On mechanical ventilation for at least 48 hours
- Affiliated to national health insurance
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundperformed within 3 hours prior to extubation | Other | patient under mechanical ventilation for at least 48 hours |
| nasofibroscopieperformed within 3 to 24 hours after extubation | Other | patient under mechanical ventilation for at least 48 hours |
Primary outcome
rate of swallowing disorders
Time frame: Within 3 to 24 hours of extubation
assessed by the Penetration-Aspiration Scale (PAS)
11 secondary outcomes
Presence (PAS score >2 for at least one of the food textures) or absence of SD evaluated by FEES
Time frame: within 3 to 24 hours following extubation
Presence (PAS score > 2 for thick liquids) or absence of severe SD, evaluated by FEES
Time frame: Within 3 to 24 hours following extubation
Relationship between the presence or absence of SD and global muscle strength
Time frame: Within 3 hours prior to extubation
Relationship between the presence or absence of SD and muscle mass evaluated by ultrasound
Time frame: Within 3 hours prior to extubation
Relationship between the presence or absence of SD and cough strength before extubation
Time frame: Before extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist
Time frame: Within 3 to 24 hours following extubation
Feasibility of the ultrasound examination
Time frame: Within 3 hours prior to extubation
Presence (PAS score > 2 for water) or absence of mild SD, evaluated by FEES
Time frame: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the otolaryngologist
Time frame: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist
Time frame: Within 3 to 24 hours following extubation
Concordance between the assessement of parameters measured during the FEES procedure by the intensivist
Time frame: Within 3 to 24 hours following extubation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derived from this study: PubMed 42276803Pineda JA, Diaz C, Plasse C, Ruiz de la Fuente JM, Duvillard C, Bozorg-Grayeli A, Pennecot C, Labruyere M, Andreu P, Roudaut JB, Taha A, Morariu-Patrichi A, Jacquier M, Sow AK, Fournel I, Quenot JP. Use of ultrasound for early detection of ICU patients at risk of acquiring swallowing disorders: EIDAR, a prospective diagnostic study protocol. BMJ Open. 2026 Jun 11;16(6):e117547. doi: 10.1136/bmjopen-2026-117547.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and nasofibroscopie in people with Patient Under Mechanical Ventilation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Arturo PINEDA MASEGOSA (03 80 29 37 51 ext. +33, josearturo.pinedamasegosa@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of swallowing disorders (time frame: Within 3 to 24 hours of extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.