Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia

NCT ID: NCT06369337

Last Updated: 2024-07-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

group control

undeveloped dysphagia

Ultrasound

Intervention Type: 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.

Group cohort

Developed dysphagia

Ultrasound

Intervention Type: 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.

Interventions

Ultrasound

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Physical function; Swallowing function

Eligibility Criteria

Inclusion Criteria

• • Subjects >18 years old.

• Having received an episode of orotracheal intubation for >48h

Exclusion Criteria

• • 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: collaborator

Universidad Europea de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Teresa Fernandez Pardo

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Teresa E Fernandez-Pardo, Msc

Role: CONTACT

teresa.fernandez@universidadeuropea.es

0034650193112

Other Identifiers

014-24

Identifier Type: -

Identifier Source: org_study_id