Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia

NCT06369337 | Not Yet Recruiting

• 1 other identifier: 014-24
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Conditions

Dysphagia, Oropharyngeal; Deglutition Disorders; Mechanical Ventilation Complication

Keywords

Dysphagia; Ultrasonography; Deglutition disorders; Diagnostic Imaging; Mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 hours after authorization of oral tolerance in the patient.

Secondary Outcomes (5)

• Muscle strength

  24 hours after authorization of oral tolerance in the patient.

• Functional Status

  24 hours after authorization of oral tolerance in the patient.

• Swallowing function

  24 hours after authorization of oral tolerance in the patient.

• Swallowing function

  24 hours after authorization of oral tolerance in the patient.

• Swallowing function

  24 hours after authorization of oral tolerance in the patient.

Study Arms (2)

group control

undeveloped dysphagia

Diagnostic Test: Ultrasound

Group cohort

Developed dysphagia

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

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.

Also known as: Physical function, Swallowing function

Group cohort; group control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• Subjects \>18 years old.
• Having received an episode of orotracheal intubation for \>48h

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead
• Hospital Universitario Ramon y Cajal: collaborator

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Ultrasonography; Deglutition

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Teresa E Fernandez-Pardo, Msc

CONTACT

0034650193112; teresa.fernandez@universidadeuropea.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06