Dysphagia, OropharyngealNCT06369337
Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia
An observational study of Dysphagia, Oropharyngeal and Deglutition Disorders, run by Universidad Europea de Madrid.
Trial summary
Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysphagia, Oropharyngeal, Deglutition Disorders, Mechanical Ventilation Complication
- What is being tested?
- Ultrasound
- Type of treatment
- Pill or oral medicine
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to any of these units who have required IMV for a period greater than 48 hours who meet the eligibility criteria
Who may be able to join
- • Subjects >18 years old.
- Having received an episode of orotracheal intubation for >48h
Who cannot join
- • Congenital or acquired conditions of the Central Nervous System (CNS) such as stroke, traumatic brain injury, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis (ALS) or any other condition that may bias the attribution of dysphagia to factors other than exclusively clinical ones.
- Involvement of the cranial nerves or the Peripheral Nervous System (PNS) as well as diseases of the neuromuscular junction such as Myasthenia Gravis or any other condition that may bias the attribution of dysphagia to other factors that are not exclusively clinical.
- Neck morphology incompatible with exploration through ultrasound procedures.
- Secondary musculoskeletal injuries, including vertebral fractures, unstable extremity fractures or any condition that requires absolute bed rest as prescribed by a doctor.
- Malignant tumor lesions or previous head and/or neck surgeries.
- Medical-surgical history due to pathology of the larynx, oropharynx and/or esophagus.
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- Diagnosis of dysphagia or swallowing disorders prior to the intubation episode with IMV.
- Patients unable to eat orally, at least partially.
- Known prior cognitive impairment upon admission to the ICU.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Study of the Submentonian Musculature and Its Relationship in the Development of Dysphagia After Invasive Mechanical Ventilation: a Single-center Cohort Study
Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated >48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with >48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects >18 years old, admitted to an intensive care unit (ICU), with >48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics
- Being tested
- Ultrasound
- Keywords
- Dysphagia, Ultrasonography, Deglutition disorders, Diagnostic Imaging, Mechanical ventilation
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Also called Physical function, Swallowing function
The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). The ecographic measurements will be made of the thickness and echogenicity of the submental and tonue muscles, as well as hyolaryngeal kinematics. These measurements will be performed 48 hours from the start of the orotracheal intubation episode, 7 days and 14 days of mechanical ventilation. To enable the correlation of clinical and ultrasound variables, one more independent measurement will be performed within the first 24 hours after authorization of oral tolerance in the patient.
| Study group | Role | What they receive |
|---|---|---|
| group control | undeveloped dysphagia Receives: Diagnostic Test: Ultrasound | |
| Group cohort | Developed dysphagia Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the submental muscles
A measurement of the thickness of the digastric muscles will be performed, which will range from the upper to the lower fascial limit of the muscular belly, in its thickest territory and perpendicular to the superficial fascia of the mylohyoid muscle. The measurement of the thickness of the mylohyoid musculature will be carried out in two locations: (1) immediately below the measurement obtained for the left digastric muscle, between the limits of the superficial and deep fascia that surround it and (2) in its central raphe. The measurement of the thickness of the geniohyoid and genioglossus muscles will be carried out in their most central location, with a perpendicular line drawn from the raphe of the mylohyoid to the inferior fascia of the tongue. Finally, the thickness of the tongue will be made from the lower to the upper fascial edge, on the same line drawn for the genihyoid and Genioglossal muscles.
Measured: Baseline, 7 days, 14 days and 24 hours after authorization of oral tolerance in the patient.
Hyolaryngeal displacement
the convex probe will be used, placed longitudinally along the midline that follows the arrangement of the throat and the prominence of the thyroid cartilage. Two hyperechoic lines will be located, separated from each other, corresponding to the hyoid bone (cranial) and the most superior aspect of the ossification of the thyroid cartilage (caudal), which offer a posterior acoustic shadow artifact. 3 repetitions of a swallowing maneuver of a bolus of 3mL of water will be requested, with a rest interval of 1 to 2 minutes. These maneuvers will be recorded in video format for subsequent analysis with Image J Software (v 1.37; National Institutes of Health, Rockville, MD, USA). Each video will be analyzed frame by frame, selecting the most representative of the distances "a" (distance at rest) and "b" (maximum hyolaryngeal approximation). The result of this variable will be expressed in centimeters (cm) and % of approximation.
Measured: 24 hours after authorization of oral tolerance in the patient.
Secondary outcomes (5)
Muscle strength
Medical Research Council (MRC) Scale: this is a valid and reliable measure of the level of global muscle strength, widely used in the context of critically ill patients. It consists of 6 manual tests rated 0 (total absence of contraction) and 5 (preserved muscle capacity) applied bilaterally on different muscle groups of the upper and lower extremity, including: shoulder abduction, elbow flexion, wrist extension, flexion hip, knee extension and ankle dorsiflexion.
Measured: 24 hours after authorization of oral tolerance in the patient.
Functional Status
Functional Status Score for the ICU Scale (FSS-UCI): allows the evaluation of 5 basic functional tasks both in the critically ill patient and in the patient admitted to the ward and after being discharged from the hospital, which include: turning, transfer from supine to sitting, sitting at the edge of the bed, transferring from sitting to standing and walking.
The minimum value is 0 (non functional) and the maximum value is 7 (very functional)
Measured: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Volume-Viscosity Swallow Test Scale (VVS-T): The VVS-T scale is a valid and reliable method for the detection of dysphagia, consisting of a protocol designed to maintain the safety and effectiveness of the patient's swallowing and directing the detection of silent bronchial aspiration episodes. Evaluates 3 types of texture with different viscosity (liquid texture -water-, nectar and pudding) at 3 volumes (5mL, 10mL and 20mL) to detect signs associated with safety (tone of voice, cough or desaturation) and with the effectiveness of swallowing (lip seal, oral residue, fractional swallow or pharyngeal residue).
Measured: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Functional Oral Intake Scale (FOIS): the FOIS scale is currently one of the clinical tools for the evaluation of swallowing most accepted by scientific literature. It offers 7 levels of functionality (minimum value is 0 (non functional and maxim value is 7, very functional) in decreasing order of severity, divided into several blocks depending on the type of feeding (oral exclusively or dependent on alternative feeding).
Measured: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Gugging Swallowing Screen Scale (GUSS): the GUSS scale provides another valid and reliable clinical alternative for the assessment of dysphagia. This scale is divided into two parts, an indirect swallowing test (up to 5 points) and another direct swallowing test, in turn subdivided into 3 sections (up to 5 points each). The indirect swallowing test includes a vigilance phase, a cough/throat-clearing maneuver, and saliva swallowing. The direct swallow test specifically evaluates swallowing, involuntary coughing, drooling, and/or voice change during the ingestion of semisolids, liquids, and solids.
In this scale the minimun value is 0 and the maximum value is 20.This test allows screening the severity of dysphagia as mild or absent with minimal risk of aspiration (20 points), mild with low risk of aspiration (15-19), moderate with risk of aspiration (10-14) and severe with high risk. suction (0-9).
Measured: 24 hours after authorization of oral tolerance in the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startJun 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, OropharyngealStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Responsible party
- Principal investigator, Teresa Fernandez Pardo, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369337
- Sponsor's protocol ID
- 014-24
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Study of the Submentonian Musculature and Its Relationship in the Development of Dysphagia After Invasive Mechanical Ventilation: a Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT06369337
- Acronym / sponsor ID
- 014-24
- Keywords
- Dysphagia, Ultrasonography, Deglutition disorders, Diagnostic Imaging, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal
- Study start
- Jun 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Apr 2024 (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.
Acquired dysphagia is one of the most frequent complications suffered by patients in intensive care units (ICU) after orotracheal extubation. Ultrasound has proven to be a useful method in the morphological and kinematic exploration of the main swallowing structures. AIM: to evaluate, through ultrasound procedures, the evolution of the morphology of the tongue and muscles of the floor of the mouth and the hyolaryngeal kinematics in patients intubated >48h and to correlate these measurements with the possible development of acquired dysphagia. The incidence of dysphagia and ICU acquired weakness (ICUAW) in subjects with >48h of intubation and the relative risk factors associated with baseline characteristics and clinical variables will be described. METHODOLOGY: Design: Single-center cohort study (Ramón y Cajal University Hospital). Participants: subjects >18 years old, admitted to an intensive care unit (ICU), with >48 hours of orotracheal intubation who meet eligibility criteria. Outcomes: the study of socio-demographic and clinical variables related to ICU admission will be included. The physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). Measurements will be made of the thickness and echogenicity of the submental and tongue muscles, as well as hyolaryngeal kinematics
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group control | – | Diagnostic Test: Ultrasoundundeveloped dysphagia |
| Group cohort | – | Diagnostic Test: UltrasoundDeveloped dysphagia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to any of these units who have required IMV for a period greater than 48 hours who meet the eligibility criteria
Key inclusion criteria (2 listed)
- • Subjects >18 years old.
Key exclusion criteria (9 listed)
- • Congenital or acquired conditions of the Central Nervous System (CNS) such as stroke, traumatic brain injury, Parkinson's, multiple sclerosis, amyotrophic lateral sclerosis (ALS) or any other condition that may bias the attribution of dysphagia to factors other than exclusively clinical ones.
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 |
|---|---|---|
| UltrasoundAlso: Physical function, Swallowing functionThe physical function variables will be analyzed through the Medical Research Council (MRC) and Functional Status Score (FSS), as well as swallowing function variables through the Volume-Viscosity Swallow (VVS-T) and Functional Oral Intake Scale scales. (FOIS) and Gugging Swallowing Screen (GUSS). The ecographic measurements will be made of the thickness and echogenicity of the submental and tonue muscles, as well as hyolaryngeal kinematics. These measurements will be performed 48 hours from the start of the orotracheal intubation episode, 7 days and 14 days of mechanical ventilation. To enable the correlation of clinical and ultrasound variables, one more independent measurement will be performed within the first 24 hours after authorization of oral tolerance in the patient. | Diagnostic test | Group cohort, group control |
Primary outcome
Thickness of the submental muscles
Time frame: Baseline, 7 days, 14 days and 24 hours after authorization of oral tolerance in the patient.
A measurement of the thickness of the digastric muscles will be performed, which will range from the upper to the lower fascial limit of the muscular belly, in its thickest territory and perpendicular to the superficial fascia of the mylohyoid muscle. The measurement of the thickness of the mylohyoid musculature will be carried out in two locations: (1) immediately below the measurement obtained for the left digastric muscle, between the limits of the superficial and deep fascia that surround it and (2) in its central raphe. The measurement of the thickness of the geniohyoid and genioglossus muscles will be carried out in their most central location, with a perpendicular line drawn from the raphe of the mylohyoid to the inferior fascia of the tongue. Finally, the thickness of the tongue will be made from the lower to the upper fascial edge, on the same line drawn for the genihyoid and Genioglossal muscles.
Hyolaryngeal displacement
Time frame: 24 hours after authorization of oral tolerance in the patient.
the convex probe will be used, placed longitudinally along the midline that follows the arrangement of the throat and the prominence of the thyroid cartilage. Two hyperechoic lines will be located, separated from each other, corresponding to the hyoid bone (cranial) and the most superior aspect of the ossification of the thyroid cartilage (caudal), which offer a posterior acoustic shadow artifact. 3 repetitions of a swallowing maneuver of a bolus of 3mL of water will be requested, with a rest interval of 1 to 2 minutes. These maneuvers will be recorded in video format for subsequent analysis with Image J Software (v 1.37; National Institutes of Health, Rockville, MD, USA). Each video will be analyzed frame by frame, selecting the most representative of the distances "a" (distance at rest) and "b" (maximum hyolaryngeal approximation). The result of this variable will be expressed in centimeters (cm) and % of approximation.
5 secondary outcomes
Muscle strength
Time frame: 24 hours after authorization of oral tolerance in the patient.
Functional Status
Time frame: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Time frame: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Time frame: 24 hours after authorization of oral tolerance in the patient.
Swallowing function
Time frame: 24 hours after authorization of oral tolerance in the patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, Oropharyngeal and Deglutition Disorders, run by Universidad Europea de Madrid.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa E Fernandez-Pardo, Msc (0034650193112, teresa.fernandez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness of the submental muscles (time frame: Baseline, 7 days, 14 days and 24 hours after authorization of oral tolerance in the patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2024.