Clinical trial NCT06369337: Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dysphagia, Oropharyngeal
Deglutition Disorders
Mechanical Ventilation Complication
Keywords: Dysphagia
Ultrasonography
Deglutition disorders
Diagnostic Imaging
Mechanical ventilation
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
First posted: 2024-04-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


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.

Primary outcomes:
measure: Thickness of the submental muscles
timeFrame: Baseline, 7 days, 14 days and 24 hours after authorization of oral tolerance in the patient.
measure: Hyolaryngeal displacement
timeFrame: 24 hours after authorization of oral tolerance in the patient.
Secondary outcomes:
measure: Muscle strength
timeFrame: 24 hours after authorization of oral tolerance in the patient.
measure: Functional Status
timeFrame: 24 hours after authorization of oral tolerance in the patient.
measure: Swallowing function
timeFrame: 24 hours after authorization of oral tolerance in the patient.
measure: Swallowing function
timeFrame: 24 hours after authorization of oral tolerance in the patient.
measure: Swallowing function
timeFrame: 24 hours after authorization of oral tolerance in the patient.
Other outcomes:
Locations:
Study officials:
References: