Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369337
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-04-12
Brief Title:
Ultrasound Study of the Submentonian Musculature and Its Relationship in Dysphagia
Sponsor:
Universidad Europea de Madrid
Organization:
Universidad Europea de Madrid
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None