Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563960
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-01
Brief Title:
Effect of Carbonated Water on Swallowing
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Carbonated Water on Swallowing in Patients With Liquid Dysphagia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Swallowing has an important function in the lives of individuals it is related to moments of socialization pleasure nutrition and also helps protect against the entry of food saliva or other material towards the lungs penetration andor laryngotracheal aspiration A Difficulty in swallowing is called dysphagia and therapeutic strategies are necessary to help the affected individuals The use of carbonated water as a therapeutic strategy has been used however there are still few studies on the topic In the search for therapeutic strategies viable and easy to insert into the clinical routine and daily lives of patients this study aims to verify the effect of carbonated water on swallowing liquids for patients with dysphagia diagnosed by videodeglutogram examination through comparison with non-water carbonated The present study aims to generate scientific evidence about the effect of water carbonated drink as a strategy in patients with liquid dysphagia with the aim of helping professional speech therapist and other professionals involved in the therapeutic process in order to improve the health and quality of life of dysphagic patients and contribute to the evolution of knowledge in the field of dysphagia This is a clinical trial all participants will be included adult patients to carry out the video swallow examination which present aspiration andor laryngotracheal penetration of liquids during the performance of the and who agree to participate in the research The effect of carbonated water on levels of penetration andor laryngotracheal aspiration in relation to the use of non-carbonated water and analyzed whether the results obtained with the use of carbonated water have behavior similar between the different patient profiles studied
Detailed Description:
This is a clinical trial The study population comprises all adult dysphagic patients who present laryngotracheal penetration andor aspiration of liquids during the videodeglutogram exam performed at the aforementioned Imaging Diagnosis Center during the period from March to December 2023 and who agree to participate Therefore a convenience sample will be used
The study population will consist of all patients who present laryngotracheal penetration andor aspiration of liquids during the videodeglutogram exam performed at the institutions Imaging Diagnosis Center and who agree to participate in the study The anamnesis was constructed by the research team aiming to collect information about the target population age sex marital status education underlying pathology main complaint and swallowing difficulties In addition for those who have a history in the electronic medical record the same will be consulted to verify information regarding the history of previous illnesses medications in use and general health conditions The examination will be performed by the technically responsible speech therapist with experience in the area It consists of offering food to the patient thin liquid - water moderately thickened - yogurt soft solid - bread and hard - crackers impregnated with a barium contrast during swallowing dynamic real-time images are captured by an x-ray equipment making it possible to evaluate all phases of swallowing following the path of the food from the mouth to the stomach The following aspects will be checked oral preparation of the food ejection of the bolus the existence of early food escape and identification of the location of the beginning of the pharyngeal phase of swallowing the presence of stasis in valleculae and pyriform sinuses episodes of laryngotracheal penetration andor aspiration and changes in esophageal motility Some compensatory strategies such as head positioning and airway protection maneuvers may be tested during the examination Patients who present laryngotracheal penetration andor aspiration with thin liquid will be subjected to the ingestion of carbonated water in order to verify whether there will be a change in the pattern of laryngotracheal penetration andor aspiration The carbonated water chosen for the study was the brand for every 60ml of water 18ml of barium 3 concentration will be mixed the contrast required for the images to be captured in the videofluoroscopy examination To classify the functional severity of dysphagia and describe laryngotracheal penetration andor aspiration the following scales will be considered Dysphagia Outcome and Severity Scale DOSS and Rosenbek Scale The classification for evaluating the biomechanics of swallowing will be made based on the results of the videofluoroscopy exam which will be performed
The study population will consist of all patients who present laryngotracheal penetration andor aspiration of liquids during the videodeglutogram exam performed at the institutions Imaging Diagnosis Center and who agree to participate in the study The anamnesis was constructed by the research team aiming to collect information about the target population age sex marital status education underlying pathology main complaint and swallowing difficulties In addition for those who have a history in the electronic medical record the same will be consulted to verify information regarding the history of previous illnesses medications in use and general health conditions The examination will be performed by the technically responsible speech therapist with experience in the area It consists of offering food to the patient thin liquid - water moderately thickened - yogurt soft solid - bread and hard - crackers impregnated with a barium contrast during swallowing dynamic real-time images are captured by an x-ray equipment making it possible to evaluate all phases of swallowing following the path of the food from the mouth to the stomach The following aspects will be checked oral preparation of the food ejection of the bolus the existence of early food escape and identification of the location of the beginning of the pharyngeal phase of swallowing the presence of stasis in valleculae and pyriform sinuses episodes of laryngotracheal penetration andor aspiration and changes in esophageal motility Some compensatory strategies such as head positioning and airway protection maneuvers may be tested during the examination Patients who present laryngotracheal penetration andor aspiration with thin liquid will be subjected to the ingestion of carbonated water in order to verify whether there will be a change in the pattern of laryngotracheal penetration andor aspiration The carbonated water chosen for the study was the brand for every 60ml of water 18ml of barium 3 concentration will be mixed the contrast required for the images to be captured in the videofluoroscopy examination To classify the functional severity of dysphagia and describe laryngotracheal penetration andor aspiration the following scales will be considered Dysphagia Outcome and Severity Scale DOSS and Rosenbek Scale The classification for evaluating the biomechanics of swallowing will be made based on the results of the videofluoroscopy exam which will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None